Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients... | NCT00895895 | Trialant
NCT00895895
Sponsor
Pfizer
Status
Terminated
Last Update Posted
Jan 31, 2013Estimated
Enrollment
526Actual
Phase
Phase 2
Conditions
Alzheimer Disease
Interventions
Placebo
SAM-531 1.5 mg
SAM-531 3.0 mg
SAM-531 5.0 mg
Donepezil
Countries
United States
Argentina
Chile
Colombia
Hong Kong
Japan
Mexico
New Zealand
Poland
Romania
Russia
South Africa
South Korea
Protocol Section
Identification Module
NCT ID
NCT00895895
Obsolete or Duplicate NCT IDs
NCT01312896
Organization Study
3193A1-2005
Secondary IDs
ID
Type
Description
Link
B1961007
Brief Title
Study Comparing 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
Official Title
A 52-Week, Two-Period, Multicenter, Randomized, Double-Blind, Donepezil-Referenced, Placebo-Controlled, Efficacy And Safety Study Of 3 Dosage Levels Of SAM-531 In Outpatients With Mild To Moderate Alzheimer Disease
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Dec 2012
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
See termination reason in detailed description.
Expanded Access Info
No
Start Date
May 2009
Primary Completion Date
May 2011Actual
Completion Date
May 2011Actual
First Submitted Date
May 7, 2009
First Submission Date that Met QC Criteria
May 7, 2009
First Posted Date
May 8, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 21, 2012
Results First Submitted that Met QC Criteria
Dec 21, 2012
Results First Posted Date
Jan 31, 2013Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 21, 2012
Last Update Posted Date
Jan 31, 2013Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The study will evaluate the efficacy and safety of an investigational drug called SAM-531 at three dosage levels. Subjects will receive either one of the 3 dosage levels of SAM-531, donepezil or placebo for the first 24 weeks of the study (period I). Subjects who receive placebo for period I will be assigned to receive the highest dose of SAM-531 SAM-531 for the remaining 28 weeks of the study, while subjects who received one of the three SAM-531 dosage levels or donepezil in period I will continue with the same study drug (period II).
Detailed Description
The study was stopped (date of termination was 13April2011) due to a 6 month interim analysis: all of the 3 SAM-531 dosage levels were declared futile. There were no safety concerns.
Conditions Module
Conditions
Alzheimer Disease
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
526Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
1
Placebo Comparator
Placebo
Drug: Placebo
2
Experimental
SAM-531 1.5 mg
Drug: SAM-531 1.5 mg
3
Experimental
SAM-531 3.0 mg
Drug: SAM-531 3.0 mg
4
Experimental
SAM-531 5.0 mg
Drug: SAM-531 5.0 mg
5
Active Comparator
Donepezil
Drug: Donepezil
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Capsules SAM-531 placebo and 5 mg tablet encapsulated Donepezil placebo capsules, once a day during 24 weeks.
1
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24
14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scores (items 1-11) and ranged from 0 to 70 with higher scores indicating greater cognitive impairment.
Baseline, Week 24
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24
Caregiver interview-based instrument assessing 10 areas of activities of daily living (ADL) to measure participant's actual performance over the previous 2 weeks. Items included hygiene, dressing, continence, eating, meal preparation, telephoning, outings, finance/correspondence, medications and leisure/housework. Responses scored as 1 (yes) or 0 (no), response of "Not Applicable" was not scored. Total DAD score was sum of scores for 40 items, expressed as a percentage of the number of items answered yes or no. Total score ranged from 0 to 100, higher scores represented less disability in ADL.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of probable Alzheimer Disease according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Diseases and Related Disorders Association (NINCDS-ADRDA) criteria.
Mini-Mental State Examination (MMSE) score of 12 to 24 at screening
Rosen Modified Hachinski Ischemic score < or equal to 4 at screening.
Exclusion Criteria:
Relevant neurologic disease other than Alzheimer Disease that may affect cognition or ability to complete the study.
Current major depressive disorder or other current major psychiatric disorder.
History of clinically evident stroke or clinically important carotid or vertebrobasilar stenosis or plaque.
Use of prescription or nonprescription medications for cognitive enhancement (including memantine, ginkgo biloba, huperzine A, and cholinesterase inhibitors) within 3 months before the baseline visit.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
50 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pfizer Investigational Site
Phoenix
Arizona
85004
United States
Pfizer Investigational Site
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Periods
Title
Milestones
Reasons Not Completed
Period 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
SAM-531 1.5 mg
Drug
Capsules SAM-531 1.5 mg, once a day during 52 weeks.
2
SAM-531 3.0 mg
Drug
Capsules SAM-531 3.0 mg, once a day during 52 weeks.
3
SAM-531 5.0 mg
Drug
Capsules SAM-531 5.0 mg, once a day during 24 weeks or 52 weeks.
4
Donepezil
Drug
Encapsulated Donepezil 5 mg tablets, once a day during 52 weeks. After Day 42, the dose can up titrated up to 10 mg of Donepezil.
5
Baseline, Week 24
Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24
Caregiver interview-based rating scale assessed 10 behavioral, 2 neurovegetative disturbances occurring in dementia: delusions, hallucination, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, appetite/eating disorders and sleep/nightime behavior disorders. Each symptom score derived by symptom frequency (1 [occasionally] to 4 [very frequently] * symptom severity (1 [mild] to 3 [severe]) and ranged 0-12. Total score = sum of symptom scores; range 0-144, higher score indicating greater behavioral disturbances
Baseline, Week 24
Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24
Caregiver and participant interview-based tool to rate the overall impression of participant's clinical change of the disease over time. Areas covered in the interview include: relevant history, observation/evaluation, mental/cognitive state, behavior and functioning. Change categorized into 1 of 7 categories: marked improvement, moderate improvement, minimal improvement, no change, minimal worsening, moderate worsening, marked worsening.
Baseline, Week 24
Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total Errors=total number of incorrect boxes chosen plus adjustment for estimated possible errors on problems, attempts, and recalls not reached. Total score 0 to 106, lower scores=better performance.
Baseline, Week 24
Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of patterns presented at last stage successfully completed and ranged from 2 to 6, higher scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of correct choices made on the first attempt at each Stage. Total score ranged from 0 to 20, higher scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 4 box assessments the maximum number of errors per trial was 20. Test ended with 20 errors in a trial. Less than 20 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 39. Lower scores: better performance.
Baseline, Week 24
Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 6 box assessments the maximum number of errors per trial was 30. Test ended with 30 errors in a trial. Less than 30 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 59. Lower scores: better performance.
Baseline, Week 24
Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 8 box assessments the maximum number of errors per trial was 40. Test ended with 40 errors in a trial. Less than 40 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 79. Lower scores: better performance.
Baseline, Week 24
Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials for each assessment. Possible errors for each successful assessment: 4 box 0-38; 6 box 0-58; 8 box 0-78. Between Errors for N Boxes was the cumulative number of errors per each successful trial. Total scores ranged from 0 to 175. Lower scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB SWM Strategy at Week 24
CANTAB-SWM assessed participant's ability to strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials per assessment. Strategy score was the number of unique boxes the participant searched in the two 6 and 8 box trials. 6 box trial scores ranged from 1 (1 box searched for all 6 tokens) to 6 (6 boxes searched for 6 tokens). 8 box trial score ranged from 1 (1 box searched) to 8 (8 boxes searched for 8 tokens). Total of the 4 trial scores ranged from 4 to 28. Lower score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24
CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Latency in correct responses ranged from 0 to infinity millisecond (msec), lower scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB PRM-Percentage Correct at Week 24
CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Correct response total expressed as a percentage, ranged from 0 to 100, higher scores indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during a 5-choice reaction time trial and to measure anticipatory/premature and perseverative responses. In the trial, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Accuracy was the total number of trials where participant responded correctly. Total ranged from 0 to 30, higher score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Movement Time was the time from release of press pad to screen touch where the spot had been in trials the participant responded correctly. Possible score ranged from 100 to 5100 msec, lower score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB RTI Simple Movement Time at Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Movement Time was the time from release of press pad to touch the screen where the spot had been in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
Baseline, Week 24
Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
Baseline, Week 24
Percentage of Participants Who Were Responders at Week 24
Responder defined as a participant who demonstrated an improvement of at least 3 points from baseline in the ADAS-Cog total score and no worsening in the DAD total score and in ADCS-CGIC. Participants were considered a responder at Week 24 if all 3 criteria were met.
Week 24
Phoenix
Arizona
85050
United States
Pfizer Investigational Site
Costa Mesa
California
92626
United States
Pfizer Investigational Site
Fresno
California
93720
United States
Pfizer Investigational Site
Garden Grove
California
92845
United States
Pfizer Investigational Site
Long Beach
California
90806
United States
Pfizer Investigational Site
Oxnard
California
93030
United States
Pfizer Investigational Site
Denver
Colorado
80218
United States
Pfizer Investigational Site
Denver
Colorado
80239
United States
Pfizer Investigational Site
Atlantis
Florida
33462
United States
Pfizer Investigational Site
Brooksville
Florida
34601
United States
Pfizer Investigational Site
Hallandale
Florida
33009
United States
Pfizer Investigational Site
Miami
Florida
33180
United States
Pfizer Investigational Site
Naples
Florida
34102
United States
Pfizer Investigational Site
Plantation
Florida
33317
United States
Pfizer Investigational Site
St. Petersburg
Florida
33702
United States
Pfizer Investigational Site
St. Petersburg
Florida
33709
United States
Pfizer Investigational Site
Sunrise
Florida
33351
United States
Pfizer Investigational Site
Tampa
Florida
33613
United States
Pfizer Investigational Site
West Palm Beach
Florida
33407
United States
Pfizer Investigational Site
Atlanta
Georgia
30308
United States
Pfizer Investigational Site
Elk Grove Village
Illinois
60007
United States
Pfizer Investigational Site
Park Ridge
Illinois
60068
United States
Pfizer Investigational Site
St Louis
Missouri
63104
United States
Pfizer Investigational Site
St Louis
Missouri
63110
United States
Pfizer Investigational Site
Cedarhurst
New York
11516
United States
Pfizer Investigational Site
Staten Island
New York
10312
United States
Pfizer Investigational Site
Toledo
Ohio
43623
United States
Pfizer Investigational Site
Oklahoma City
Oklahoma
73103
United States
Pfizer Investigational Site
Oklahoma City
Oklahoma
73112
United States
Pfizer Investigational Site
Oklahoma City
Oklahoma
73116
United States
Pfizer Investigational Site
Tulsa
Oklahoma
74104
United States
Pfizer Investigational Site
Portland
Oregon
97210
United States
Pfizer Investigational Site
Allentown
Pennsylvania
18104
United States
Pfizer Investigational Site
Franklin
Tennessee
37067
United States
Pfizer Investigational Site
Bennington
Vermont
05201
United States
Pfizer Investigational Site
Middleton
Wisconsin
53562
United States
Pfizer Investigational Site
C.a.b.a.
Buenos Aires
C1126AAB
Argentina
Pfizer Investigational Site
Caba
Buenos Aires
1022
Argentina
Pfizer Investigational Site
Ciudad de Buenos Aires
1022
Argentina
Pfizer Investigational Site
Ciudad de Buenos Aires
C1425BWO
Argentina
Pfizer Investigational Site
Santiago
Chile
7500922
Chile
Pfizer Investigational Site
Santiago
Chile
7530193
Chile
Pfizer Investigational Site
Santiago
Chile
7630000
Chile
Pfizer Investigational Site
Santiago
Chile
8330838
Chile
Pfizer Investigational Site
Viña del Mar
Chile
2520997
Chile
Pfizer Investigational Site
Bogota
Cundinamarca
Colombia
Pfizer Investigational Site
Pereira
Risaralda Department
Colombia
Pfizer Investigational Site
Bucamaranga
Santander Department
Colombia
Pfizer Investigational Site
Cali
Valle del Cauca Department
Colombia
Pfizer Investigational Site
Valle Del Cauca
Colombia
Pfizer Investigational Site
Shatin, N.T.
Hong Kong SAR, China
Hong Kong
Pfizer Investigational Site
Hong Kong
Hong Kong
Pfizer Investigational Site
Hachiōji
Tokyo
Japan
Pfizer Investigational Site
Chiba
Japan
Pfizer Investigational Site
Fukuoka
Japan
Pfizer Investigational Site
Hiroshima
Japan
Pfizer Investigational Site
Kanagawa
Japan
Pfizer Investigational Site
Kumamoto
Japan
Pfizer Investigational Site
Kyoto
Japan
Pfizer Investigational Site
Nagano
Japan
Pfizer Investigational Site
Nagasaki
Japan
Pfizer Investigational Site
Shizuoka
Japan
Pfizer Investigational Site
Saltillo
Coahuila
25000
Mexico
Pfizer Investigational Site
Aguascalientes
20127
Mexico
Pfizer Investigational Site
Auckland
0622
New Zealand
Pfizer Investigational Site
Hamilton
3240
New Zealand
Pfizer Investigational Site
Krakow
Poland
31-531
Poland
Pfizer Investigational Site
Poznan
Poland
61-289
Poland
Pfizer Investigational Site
Wroclaw
Poland
50-088
Poland
Pfizer Investigational Site
Krakow
31-531
Poland
Pfizer Investigational Site
Craiova
Dolj
200317
Romania
Pfizer Investigational Site
Timișoara
Timiș County
300736
Romania
Pfizer Investigational Site
Bucharest
010825
Romania
Pfizer Investigational Site
Bucharest
011241
Romania
Pfizer Investigational Site
Bucharest
041914
Romania
Pfizer Investigational Site
Bucharest
050098
Romania
Pfizer Investigational Site
Nikolskoe Village
Gatchina District, Leningrad Region
188357
Russia
Pfizer Investigational Site
Kazan'
420101
Russia
Pfizer Investigational Site
Moscow
115522
Russia
Pfizer Investigational Site
Moscow
123182
Russia
Pfizer Investigational Site
Novosibirsk
630054
Russia
Pfizer Investigational Site
Saint Petersburg
190005
Russia
Pfizer Investigational Site
Saint Petersburg
192019
Russia
Pfizer Investigational Site
Saint Petersburg
194044
Russia
Pfizer Investigational Site
Saint Petersburg
197022
Russia
Pfizer Investigational Site
Saint Petersburg
198103
Russia
Pfizer Investigational Site
Smolensk
214018
Russia
Pfizer Investigational Site
Yaroslavl
150030
Russia
Pfizer Investigational Site
Bloemfontein
Free State
9301
South Africa
Pfizer Investigational Site
Johannesburg
Gauteng
2196
South Africa
Pfizer Investigational Site
Pretoria
Gauteng
0041
South Africa
Pfizer Investigational Site
Bellville
Western Cape
7530
South Africa
Pfizer Investigational Site
Cape Town
7530
South Africa
Pfizer Investigational Site
Seongnam-si
Gyeonggi-do
463-707
South Korea
Pfizer Investigational Site
Seoul
138-736
South Korea
FG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
FG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
FG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
FG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
FG000107 subjects
FG001105 subjects
FG002104 subjects
FG003104 subjects
FG004106 subjects
Randomized But Not Treated
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG0042 subjects
COMPLETED
FG00086 subjects
FG00184 subjects
FG00284 subjects
FG00391 subjects
FG00486 subjects
NOT COMPLETED
FG00021 subjects
FG00121 subjects
FG00220 subjects
FG00313 subjects
FG00420 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0016 subjects
FG0024 subjects
FG0036 subjects
FG0047 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
discontinued by sponsor
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
failed to return
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
investigator request
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0011 subjects
FG0023 subjects
FG0032 subjects
FG004
Other
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0006 subjects
FG0016 subjects
FG0028 subjects
FG0032 subjects
FG004
unsatisfactory response-efficacy
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
randomized and not treated
FG0001 subjects
FG0013 subjects
FG0021 subjects
FG0031 subjects
FG004
After Period 1, Prior to Period 2
Type
Comment
Milestone Data
STARTED
FG00086 subjects
FG00184 subjects
FG00284 subjects
FG00391 subjects
FG00486 subjects
COMPLETED
FG00086 subjects
FG00184 subjects
FG00282 subjects
FG00391 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG003
Period 2
Type
Comment
Milestone Data
STARTED
FG00086 subjects
FG00184 subjects
FG00282 subjects
FG00391 subjects
FG00484 subjects
COMPLETED
FG00030 subjects
FG00131 subjects
FG00233 subjects
FG00337 subjects
FG004
NOT COMPLETED
FG00056 subjects
FG00153 subjects
FG00249 subjects
FG00354 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0003 subjects
FG0013 subjects
FG0025 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
BG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
BG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
BG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
BG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
BG005
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000106
BG001102
BG002103
BG003103
BG004104
BG005518
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
participants
Title
Denominators
Categories
50 to 65 years
Title
Measurements
BG00022
BG00117
BG00219
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00072
BG00170
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in the Alzheimer's Disease Assessment Scale-Cognition (ADAS-Cog) Total Score at Week 24
14-item scale to assess severity of cognitive impairment in Alzheimer's Disease. Items: word recall, naming objects and fingers, following commands, constructional praxis, ideational praxis, orientation, word recognition, recall of test instructions, spoken language ability, word-finding difficulty, comprehension of spoken language, concentration/distractibility, number cancellation and executive maze. Rating scale ranged from 0 (not present) to 5 (severe). Total score was sum of individual scores (items 1-11) and ranged from 0 to 70 with higher scores indicating greater cognitive impairment.
Intent to treat (ITT) population: randomized participants who took at least one dose of study medication, had a baseline evaluation and had at least one on-treatment post-baseline evaluation for the ADAS-Cog; Number of Participants Analyzed (N): number of evaluable participants
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00099
OG00198
OG002100
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG00023.6± 10.3
OG00124.1± 11.7
OG00223.6± 10.6
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change=Mini Mental State Examination (MMSE) Japan baseline baseline times(*)visit visit treatment treatment*visit.
0.424
Mean Difference (Final Values)
0.7
2-Sided
95
-1.0
2.3
No
Superiority or Other
Secondary
Change From Baseline in Disability Assessment for Dementia (DAD) Total Score at Week 24
Caregiver interview-based instrument assessing 10 areas of activities of daily living (ADL) to measure participant's actual performance over the previous 2 weeks. Items included hygiene, dressing, continence, eating, meal preparation, telephoning, outings, finance/correspondence, medications and leisure/housework. Responses scored as 1 (yes) or 0 (no), response of "Not Applicable" was not scored. Total DAD score was sum of scores for 40 items, expressed as a percentage of the number of items answered yes or no. Total score ranged from 0 to 100, higher scores represented less disability in ADL.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
percentage of yes answers
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
Secondary
Change From Baseline in Neuropsychiatry Inventory (NPI) at Week 24
Caregiver interview-based rating scale assessed 10 behavioral, 2 neurovegetative disturbances occurring in dementia: delusions, hallucination, agitation/aggression, depression, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability, aberrant motor behavior, appetite/eating disorders and sleep/nightime behavior disorders. Each symptom score derived by symptom frequency (1 [occasionally] to 4 [very frequently] * symptom severity (1 [mild] to 3 [severe]) and ranged 0-12. Total score = sum of symptom scores; range 0-144, higher score indicating greater behavioral disturbances
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
unit on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Number of Participants With Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC) Scores at Week 24
Caregiver and participant interview-based tool to rate the overall impression of participant's clinical change of the disease over time. Areas covered in the interview include: relevant history, observation/evaluation, mental/cognitive state, behavior and functioning. Change categorized into 1 of 7 categories: marked improvement, moderate improvement, minimal improvement, no change, minimal worsening, moderate worsening, marked worsening.
ITT; N=number of evaluable participants
Posted
Number
participants
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in Cambridge Neuropsychological Test Automated Battery (CANTAB) Paired Associate Learning (PAL)Total Errors (N, Shapes, Adjusted) at Week 24
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total Errors=total number of incorrect boxes chosen plus adjustment for estimated possible errors on problems, attempts, and recalls not reached. Total score 0 to 106, lower scores=better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
errors
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
Secondary
Change From Baseline in CANTAB PAL - Number of Patterns Reached at Week 24
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of patterns presented at last stage successfully completed and ranged from 2 to 6, higher scores indicated better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
patterns
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in CANTAB PAL - First Trial Memory Score, Patterns at Week 24
CANTAB PAL-assessed visual memory/new learning using one or more patterns randomly displayed in boxes on a screen. Participants were to touch the box where patterns first appeared. Stage 1 (practice) and difficulty increased Stage 2 (2 patterns) to Stage 6 (6 patterns). When all locations correctly identified moved to next Stage. Test terminated when a stage could not be completed in 6 attempts. Total score was the number of correct choices made on the first attempt at each Stage. Total score ranged from 0 to 20, higher scores indicated better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
correct choices
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in CANTAB Spatial Working Memory (SWM) - Between Errors (4 Boxes) at Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 4 box assessments the maximum number of errors per trial was 20. Test ended with 20 errors in a trial. Less than 20 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 39. Lower scores: better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
errors
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
Secondary
Change From Baseline in CANTAB-SWM - Between Errors (6 Boxes) at Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 6 box assessments the maximum number of errors per trial was 30. Test ended with 30 errors in a trial. Less than 30 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 59. Lower scores: better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
errors
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in CANTAB SWM - Between Errors (8 Boxes) at Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant asked to find tokens in on-screen boxes, move them. Difficulty ranged 4-8 boxes to assess, 2 trials per assessment. Between errors: number of times participant revisited a box where a token previously found. In 8 box assessments the maximum number of errors per trial was 40. Test ended with 40 errors in a trial. Less than 40 errors in both trials the participant went to the next level of difficulty. Scores ranged from 0 to 79. Lower scores: better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
errors
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in CANTAB SWM - Between Errors (N Boxes) at Week 24
CANTAB-SWM assessed participant's retention of spatial information, ability to manipulate remembered items and strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials for each assessment. Possible errors for each successful assessment: 4 box 0-38; 6 box 0-58; 8 box 0-78. Between Errors for N Boxes was the cumulative number of errors per each successful trial. Total scores ranged from 0 to 175. Lower scores indicated better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
errors
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in CANTAB SWM Strategy at Week 24
CANTAB-SWM assessed participant's ability to strategize. Participant was asked to find tokens in on-screen boxes and move them. Difficulty ranged from 4 to 8 box assessments, 2 trials per assessment. Strategy score was the number of unique boxes the participant searched in the two 6 and 8 box trials. 6 box trial scores ranged from 1 (1 box searched for all 6 tokens) to 6 (6 boxes searched for 6 tokens). 8 box trial score ranged from 1 (1 box searched) to 8 (8 boxes searched for 8 tokens). Total of the 4 trial scores ranged from 4 to 28. Lower score indicated better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
boxes
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in CANTAB Pattern Recognition Memory (PRM)-Mean Correct Latency at Week 24
CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Latency in correct responses ranged from 0 to infinity millisecond (msec), lower scores indicated better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
msec
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in CANTAB PRM-Percentage Correct at Week 24
CANTAB-PRM assessed participant's visual pattern recognition memory in a 2-choice forced discrimination paradigm. Participants presented with a series of 12 visual patterns singly. In recognition phase, participants were required to choose between a pattern previously seen and a novel pattern. Patterns in the recognition phase appeared sequentially in reverse order on the screen. Assessment was repeated with 12 new patterns. Correct response total expressed as a percentage, ranged from 0 to 100, higher scores indicated better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
percentage of correct answers
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in CANTAB Reaction Time (RTI) Five-Choice Accuracy at Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during a 5-choice reaction time trial and to measure anticipatory/premature and perseverative responses. In the trial, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Accuracy was the total number of trials where participant responded correctly. Total ranged from 0 to 30, higher score indicated better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
correct trials
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in CANTAB RTI Five-Choice Movement Time at Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Movement Time was the time from release of press pad to screen touch where the spot had been in trials the participant responded correctly. Possible score ranged from 100 to 5100 msec, lower score indicated better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
msec
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in CANTAB RTI Five-Choice Reaction Time at Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during 5-choice reaction time trial and also measured anticipatory/premature responses. In the test, a yellow spot appeared on a computer screen in 1 of 5 locations, the participant responded by letting go of a press pad and touching the screen where the spot appeared. 5-Choice Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
msec
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in CANTAB RTI Simple Movement Time at Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Movement Time was the time from release of press pad to touch the screen where the spot had been in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
msec
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Change From Baseline in CANTAB RTI Simple Reaction Time at Week 24
CANTAB-RTI assessed participant's reaction, movement time and vigilance during simple (1 choice) reaction time trial and also measured anticipatory/premature responses. In the test, 1 yellow spot appeared on a computer screen in 1 location, the participant responded by letting go of a press pad and touching the screen where the spot appeared. Simple Reaction Time was the time from appearance of yellow spot on computer screen to time to release press pad in trials the participant responded correctly. Total ranged from 100 to 5100 (maximum allowed) msec, lower score indicated better performance.
ITT; N=number of participants with evaluable data
Posted
Mean
Standard Deviation
msec
Baseline, Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Secondary
Percentage of Participants Who Were Responders at Week 24
Responder defined as a participant who demonstrated an improvement of at least 3 points from baseline in the ADAS-Cog total score and no worsening in the DAD total score and in ADCS-CGIC. Participants were considered a responder at Week 24 if all 3 criteria were met.
ITT; N=number of participants with evaluable data
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Placebo, Then SAM-531
Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG001
SAM-531 (1.5 mg)
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Time Frame
Not provided
Description
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo/5.0 mg Period 1
Matching SAM-531 placebo capsule administered QD (morning dose) and one encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 24 weeks (Period 1). From Week 7 the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
7
106
30
106
EG001
SAM-531 1.5 mg Period 1
SAM-531 1.5 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
7
102
23
102
EG002
SAM-531 3.0 mg Period 1
SAM-531 3.0 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
8
103
32
103
EG003
SAM-531 5.0 mg Period 1
SAM-531 5.0 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
4
103
37
103
EG004
Donepezil Period 1
Matching SAM-531 placebo capsule administered QD (morning dose) and 1 encapsulated Donepezil 5 mg tablet administered orally QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion and according to tolerance.
4
104
24
104
EG005
SAM-531 5.0 mg Crossover Period 2
Participants who received Placebo in Period 1, beginning in Week 25 and up to Week 52 (Period 2) received SAM-531 5.0 mg capsule administered QD (morning dose) and matching encapsulated Donepezil placebo tablet administered QD (evening dose). The evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
8
106
13
106
EG006
SAM-531 1.5 mg Period 2
SAM-531 1.5 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
2
102
13
102
EG007
SAM-531 3.0 mg Period 2
SAM-531 3.0 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
7
103
22
103
EG008
SAM-531 5.0 mg Period 2
SAM-531 5.0 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
3
103
22
103
EG009
Donepezil Period 2
Matching SAM-531 placebo capsule administered QD (morning dose) for up to 52 weeks. One encapsulated Donepezil 5 mg tablet administered orally QD (evening dose) from Week 25 up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion and according to tolerance.
7
104
19
104
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG0030 affected103 at risk
EG004
Leukocytosis
Blood and lymphatic system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Angina pectoris
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0011 affected102 at risk
EG0020 affected103 at risk
EG003
Cardiac failure chronic
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Coronary artery dissection
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Coronary artery stenosis
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Sick sinus syndrome
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Supraventricular tachycardia
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Colitis
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0011 affected102 at risk
EG0021 affected103 at risk
EG003
Chest pain
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Pain
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Asthenia
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Gait disturbance
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Pyrexia
General disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Clostridium difficile colitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0011 affected102 at risk
EG0020 affected103 at risk
EG003
Sepsis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0001 affected106 at risk
EG0011 affected102 at risk
EG0021 affected103 at risk
EG003
Cystitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0011 affected102 at risk
EG0022 affected103 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0011 affected102 at risk
EG0020 affected103 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Skeletal injury
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Subdural haematoma
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Traumatic brain injury
Injury, poisoning and procedural complications
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Influenza A virus test positive
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Troponin increased
Investigations
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Spinal column stenosis
Musculoskeletal and connective tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Lung neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0011 affected102 at risk
EG0020 affected103 at risk
EG003
Squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Lung squamous cell carcinoma stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Convulsion
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Dementia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Extrapyramidal disorder
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Normal pressure hydrocephalus
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Psychomotor hyperactivity
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Dyskinesia
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Syncope
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Aggression
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Agitation
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0011 affected102 at risk
EG0020 affected103 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Psychotic disorder
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0001 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0011 affected102 at risk
EG0020 affected103 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Stress urinary incontinence
Renal and urinary disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Atelectasis
Respiratory, thoracic and mediastinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0020 affected103 at risk
EG003
Drug eruption
Skin and subcutaneous tissue disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Aortic dissection
Vascular disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0010 affected102 at risk
EG0021 affected103 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0004 affected106 at risk
EG0011 affected102 at risk
EG0024 affected103 at risk
EG0039 affected103 at risk
EG0047 affected104 at risk
EG0050 affected106 at risk
EG0062 affected102 at risk
EG0072 affected103 at risk
EG0082 affected103 at risk
EG0092 affected104 at risk
Vomiting
Gastrointestinal disorders
MedDRA 14.0
Non-systematic Assessment
EG0005 affected106 at risk
EG0011 affected102 at risk
EG0026 affected103 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0004 affected106 at risk
EG0015 affected102 at risk
EG0022 affected103 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.0
Non-systematic Assessment
EG0007 affected106 at risk
EG0014 affected102 at risk
EG00211 affected103 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0000 affected106 at risk
EG0015 affected102 at risk
EG0027 affected103 at risk
EG003
Headache
Nervous system disorders
MedDRA 14.0
Non-systematic Assessment
EG0006 affected106 at risk
EG0016 affected102 at risk
EG0028 affected103 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 14.0
Non-systematic Assessment
EG0003 affected106 at risk
EG0011 affected102 at risk
EG0022 affected103 at risk
EG003
Hypertension
Vascular disorders
MedDRA 14.0
Non-systematic Assessment
EG0006 affected106 at risk
EG0012 affected102 at risk
EG0023 affected103 at risk
EG003
Study terminated early due to futility. Period 2 events include those that started in Period 2 or started in Period 1 and continued in to Period 2.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D000544
Alzheimer Disease
Ancestor Terms
ID
Term
D003704
Dementia
D001927
Brain Diseases
D002493
Central Nervous System Diseases
D009422
Nervous System Diseases
D024801
Tauopathies
D019636
Neurodegenerative Diseases
D019965
Neurocognitive Disorders
D001523
Mental Disorders
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C581984
SAM-531
D000077265
Donepezil
Ancestor Terms
ID
Term
D007189
Indans
D007192
Indenes
D011084
Polycyclic Aromatic Hydrocarbons
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D010880
Piperidines
D006573
Heterocyclic Compounds, 1-Ring
D006571
Heterocyclic Compounds
D011083
Polycyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
1 subjects
1 subjects
0 subjects
3 subjects
1 subjects
0 subjects
4 subjects
0 subjects
2 subjects
84 subjects
2 subjects
0 subjects
FG0040 subjects
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
35 subjects
49 subjects
2 subjects
FG0045 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
discontinued by sponsor
FG00044 subjects
FG00144 subjects
FG00238 subjects
FG00346 subjects
FG00437 subjects
failed to return
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
investigator request
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG0040 subjects
Other
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0031 subjects
FG0041 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG0041 subjects
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0033 subjects
FG0045 subjects
unsatisfactory response-efficacy
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
18
BG00420
BG00596
66 to 80 years
Title
Measurements
BG00059
BG00160
BG00254
BG00366
BG00466
BG005305
greater than 80 years
Title
Measurements
BG00025
BG00125
BG00230
BG00319
BG00418
BG005117
71
BG00373
BG00470
BG005356
Male
BG00034
BG00132
BG00232
BG00330
BG00434
BG005162
101
OG004103
22.6
± 9.8
OG00423.4± 10.0
Week 24
Title
Measurements
OG00023.8± 12.0
OG00124.2± 13.1
OG00223.5± 12.0
OG00321.9± 10.6
OG00422.4± 10.9
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change equals (=) MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.849
Mean Difference (Final Values)
-0.2
2-Sided
95
-1.8
1.5
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.520
Mean Difference (Final Values)
-0.5
2-Sided
95
-2.2
1.1
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.258
Mean Difference (Final Values)
-1.0
2-Sided
95
-2.6
0.7
No
Superiority or Other
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00097
OG00197
OG00298
OG003100
OG004102
Title
Denominators
Categories
Baseline
Title
Measurements
OG00077.4± 21.8
OG00173.1± 20.9
OG00272.9± 22.5
OG00375.5± 21.0
OG00473.2± 22.9
Week 24
Title
Measurements
OG00076.7± 24.2
OG00171.4± 25.0
OG00273.0± 24.4
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.367
Mean Difference (Final Values)
-1.6
2-Sided
95
-5.2
1.9
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.910
Mean Difference (Final Values)
0.2
2-Sided
95
-3.3
3.7
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.160
Mean Difference (Final Values)
2.5
2-Sided
95
-1.0
6.0
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.060
Mean Difference (Final Values)
3.4
2-Sided
95
-0.1
6.9
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00096
OG00196
OG00298
OG00399
OG004102
Title
Denominators
Categories
Baseline
Title
Measurements
OG00010.6± 13.9
OG00114.6± 16.6
OG00214.8± 18.1
OG00313.4± 13.4
OG00412.1± 14.8
Week 24
Title
Measurements
OG00010.7± 14.4
OG00111.9± 14.6
OG0029.7± 11.3
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.931
Mean Difference (Final Values)
0.1
2-Sided
95
-2.8
3.1
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.054
Mean Difference (Final Values)
-2.9
2-Sided
95
-5.8
0.1
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.246
Mean Difference (Final Values)
-1.7
2-Sided
95
-4.6
1.2
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.426
Mean Difference (Final Values)
-1.2
2-Sided
95
-4.1
1.7
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00086
OG00185
OG00284
OG00392
OG00487
Title
Denominators
Categories
marked improvement
Title
Measurements
OG0000
OG0011
OG0021
OG0031
OG0041
moderate improvement
Title
Measurements
OG0001
OG0012
OG0025
OG003
minimal improvement
Title
Measurements
OG00020
OG00123
OG00219
OG003
no change
Title
Measurements
OG00032
OG00136
OG00233
OG003
minimal worsening
Title
Measurements
OG00030
OG00117
OG00219
OG003
moderate worsening
Title
Measurements
OG0002
OG0015
OG0026
OG003
marked worsening
Title
Measurements
OG0001
OG0011
OG0021
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
Cochran-Mantel-Haenszel
0.265
2-Sided
No
Superiority or Other
OG000
OG001
Cochran-Mantel-Haenszel
0.682
2-Sided
No
Superiority or Other
OG000
OG002
Cochran-Mantel-Haenszel
0.532
2-Sided
No
Superiority or Other
OG000
OG003
Cochran-Mantel-Haenszel
0.087
2-Sided
No
Superiority or Other
OG000
OG004
Cochran-Mantel-Haenszel
0.751
2-Sided
No
Superiority or Other
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00094
OG00193
OG00297
OG00396
OG00498
Title
Denominators
Categories
Baseline
Title
Measurements
OG00068.3± 27.4
OG00166.9± 29.6
OG00266.5± 28.6
OG00367.6± 28.8
OG00467.8± 29.3
Week 24
Title
Measurements
OG00066.4± 27.4
OG00168.1± 29.2
OG00267.5± 29.8
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.553
Mean Difference (Final Values)
1.7
2-Sided
95
-3.9
7.3
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.886
Mean Difference (Final Values)
-0.4
2-Sided
95
-6.0
5.2
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.712
Mean Difference (Final Values)
-1.0
2-Sided
95
-6.6
4.5
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.785
Mean Difference (Final Values)
0.8
2-Sided
95
-4.8
6.4
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00094
OG00193
OG00297
OG00396
OG00498
Title
Denominators
Categories
Baseline
Title
Measurements
OG0004.1± 1.3
OG0014.2± 1.3
OG0024.2± 1.3
OG0034.1± 1.4
OG0044.1± 1.3
Week 24
Title
Measurements
OG0004.3± 1.3
OG0014.1± 1.4
OG0024.2± 1.4
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.251
Mean Difference (Final Values)
-0.2
2-Sided
95
-0.5
0.1
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.993
Mean Difference (Final Values)
-0.0
2-Sided
95
-0.3
0.3
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.553
Mean Difference (Final Values)
-0.1
2-Sided
95
-0.4
0.2
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.611
Mean Difference (Final Values)
-0.1
2-Sided
95
-0.4
0.2
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00094
OG00193
OG00297
OG00396
OG00498
Title
Denominators
Categories
Baseline
Title
Measurements
OG0004.6± 3.9
OG0014.8± 4.5
OG0024.7± 4.3
OG0034.6± 4.1
OG0044.6± 4.4
Week 24
Title
Measurements
OG0004.8± 4.0
OG0014.4± 4.2
OG0024.8± 4.5
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.340
Mean Difference (Final Values)
-0.5
2-Sided
95
-1.5
0.5
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.630
Mean Difference (Final Values)
0.2
2-Sided
95
-0.8
1.2
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.678
Mean Difference (Final Values)
0.2
2-Sided
95
-0.8
1.2
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.518
Mean Difference (Final Values)
-0.3
2-Sided
95
-1.3
0.7
No
Superiority or Other
SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00095
OG00193
OG00297
OG00397
OG00498
Title
Denominators
Categories
Baseline
Title
Measurements
OG0003.8± 2.0
OG0013.6± 2.4
OG0023.8± 2.7
OG0033.5± 2.1
OG0043.9± 2.4
Week 24
Title
Measurements
OG0003.7± 2.3
OG0013.6± 2.3
OG0023.7± 2.5
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.953
Mean Difference (Final Values)
-0.0
2-Sided
95
-0.7
0.7
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.956
Mean Difference (Final Values)
-0.0
2-Sided
95
-0.7
0.6
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.216
Mean Difference (Final Values)
-0.4
2-Sided
95
-1.1
0.2
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.665
Mean Difference (Final Values)
-0.1
2-Sided
95
-0.8
0.5
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00095
OG00193
OG00297
OG00397
OG00498
Title
Denominators
Categories
Baseline
Title
Measurements
OG0009.2± 3.9
OG0019.1± 4.2
OG0029.1± 3.9
OG0038.6± 4.0
OG00410.0± 4.8
Week 24
Title
Measurements
OG0008.9± 2.9
OG0019.2± 4.9
OG0029.0± 4.1
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.373
Mean Difference (Final Values)
0.5
2-Sided
95
-0.6
1.7
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.781
Mean Difference (Final Values)
0.2
2-Sided
95
-1.0
1.3
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.417
Mean Difference (Final Values)
0.5
2-Sided
95
-0.7
1.6
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.853
Mean Difference (Final Values)
-0.1
2-Sided
95
-1.3
1.0
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00095
OG00193
OG00297
OG00397
OG00498
Title
Denominators
Categories
Baseline
Title
Measurements
OG00020.7± 5.9
OG00120.1± 5.8
OG00220.8± 6.1
OG00319.3± 6.9
OG00420.2± 6.5
Week 24
Title
Measurements
OG00021.1± 5.6
OG00120.0± 6.4
OG00220.8± 5.4
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.428
Mean Difference (Final Values)
-0.7
2-Sided
95
-2.6
1.1
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.763
Mean Difference (Final Values)
-0.3
2-Sided
95
-2.1
1.5
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.312
Mean Difference (Final Values)
-0.9
2-Sided
95
-2.7
0.9
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.215
Mean Difference (Final Values)
-1.2
2-Sided
95
-3.0
0.7
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00095
OG00193
OG00297
OG00397
OG00498
Title
Denominators
Categories
Baseline
Title
Measurements
OG00033.8± 9.0
OG00132.8± 9.4
OG00233.7± 10.0
OG00331.4± 8.9
OG00434.2± 10.4
Week 24
Title
Measurements
OG00033.8± 7.8
OG00132.8± 10.3
OG00233.5± 9.6
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.956
Mean Difference (Final Values)
-0.1
2-Sided
95
-2.7
2.5
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.988
Mean Difference (Final Values)
-0.0
2-Sided
95
-2.6
2.5
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.890
Mean Difference (Final Values)
-0.2
2-Sided
95
-2.7
2.4
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.280
Mean Difference (Final Values)
-1.4
2-Sided
95
-4.0
1.2
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00095
OG00193
OG00297
OG00397
OG00498
Title
Denominators
Categories
Baseline
Title
Measurements
OG00019.7± 3.1
OG00119.4± 3.3
OG00219.2± 2.8
OG00319.1± 3.6
OG00419.0± 3.6
Week 24
Title
Measurements
OG00020.0± 2.2
OG00119.1± 3.3
OG00219.4± 2.3
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.154
Mean Difference (Final Values)
-0.6
2-Sided
95
-1.5
0.2
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.740
Mean Difference (Final Values)
-0.1
2-Sided
95
-1.0
0.7
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.179
Mean Difference (Final Values)
-0.6
2-Sided
95
-1.4
0.3
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.543
Mean Difference (Final Values)
0.3
2-Sided
95
-0.6
1.1
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00095
OG00196
OG00297
OG00398
OG00499
Title
Denominators
Categories
Baseline
Title
Measurements
OG0004583.7± 3121.2
OG0014121.1± 2358.8
OG0024973.4± 2784.3
OG0034216.4± 2208.6
OG0044303.0± 2705.2
Week 24
Title
Measurements
OG0004288.3± 2082.7
OG0013979.1± 3002.3
OG0023793.5± 1698.0
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.861
Mean Difference (Final Values)
-60.4
2-Sided
95
-739.7
618.8
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.007
Mean Difference (Final Values)
-926.6
2-Sided
95
-1596.9
-256.3
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.676
Mean Difference (Final Values)
141.3
2-Sided
95
-522.1
804.6
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.505
Mean Difference (Final Values)
230.6
2-Sided
95
-449.7
910.9
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00095
OG00196
OG00297
OG00398
OG00499
Title
Denominators
Categories
Baseline
Title
Measurements
OG00059.3± 18.7
OG00162.2± 18.4
OG00263.4± 17.1
OG00366.7± 17.7
OG00463.9± 18.9
Week 24
Title
Measurements
OG00059.4± 16.3
OG00163.0± 20.2
OG00264.4± 18.4
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.267
Mean Difference (Final Values)
2.8
2-Sided
95
-2.2
7.8
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.145
Mean Difference (Final Values)
3.6
2-Sided
95
-1.3
8.6
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.139
Mean Difference (Final Values)
3.7
2-Sided
95
-1.2
8.6
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.386
Mean Difference (Final Values)
2.2
2-Sided
95
-2.8
7.2
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00089
OG00193
OG00296
OG00396
OG00495
Title
Denominators
Categories
Baseline
Title
Measurements
OG00027.3± 4.4
OG00126.9± 5.8
OG00227.0± 5.6
OG00328.1± 4.4
OG00427.0± 5.4
Week 24
Title
Measurements
OG00027.8± 3.2
OG00126.7± 5.9
OG00228.1± 4.0
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.032
Mean Difference (Final Values)
-1.2
2-Sided
95
-2.3
-0.1
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.264
Mean Difference (Final Values)
0.6
2-Sided
95
-0.5
1.7
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.893
Mean Difference (Final Values)
0.1
2-Sided
95
-1.0
1.1
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.525
Mean Difference (Final Values)
0.4
2-Sided
95
-0.7
1.4
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00088
OG00193
OG00296
OG00396
OG00495
Title
Denominators
Categories
Baseline
Title
Measurements
OG000573.5± 218.6
OG001583.1± 307.5
OG002617.6± 381.9
OG003564.4± 310.0
OG004583.6± 292.8
Week 24
Title
Measurements
OG000539.9± 199.0
OG001578.8± 290.9
OG002584.7± 284.9
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.056
Mean Difference (Final Values)
60.9
2-Sided
95
-1.6
123.5
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.488
Mean Difference (Final Values)
21.8
2-Sided
95
-40.0
83.5
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.783
Mean Difference (Final Values)
8.6
2-Sided
95
-52.6
69.8
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.578
Mean Difference (Final Values)
17.6
2-Sided
95
-44.6
79.8
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00088
OG00193
OG00296
OG00396
OG00495
Title
Denominators
Categories
Baseline
Title
Measurements
OG000488.6± 275.8
OG001503.7± 215.2
OG002488.6± 200.8
OG003438.2± 172.1
OG004475.7± 205.9
Week 24
Title
Measurements
OG000447.3± 139.3
OG001483.6± 211.3
OG002473.7± 184.4
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.175
Mean Difference (Final Values)
31.1
2-Sided
95
-13.9
76.1
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.352
Mean Difference (Final Values)
21.0
2-Sided
95
-23.3
65.4
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.797
Mean Difference (Final Values)
5.7
2-Sided
95
-38.1
49.6
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.633
Mean Difference (Final Values)
-10.9
2-Sided
95
-55.6
33.9
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00089
OG00192
OG00296
OG00396
OG00495
Title
Denominators
Categories
Baseline
Title
Measurements
OG000620.4± 299.0
OG001631.2± 379.2
OG002669.0± 473.8
OG003641.2± 443.0
OG004624.0± 336.0
Week 24
Title
Measurements
OG000585.2± 253.2
OG001630.6± 359.5
OG002641.8± 366.4
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.066
Mean Difference (Final Values)
71.2
2-Sided
95
-4.7
147.0
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.598
Mean Difference (Final Values)
20.0
2-Sided
95
-54.6
94.7
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.766
Mean Difference (Final Values)
11.2
2-Sided
95
-62.9
85.3
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.378
Mean Difference (Final Values)
33.8
2-Sided
95
-41.5
109.1
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
Units
Counts
Participants
OG00089
OG00192
OG00296
OG00396
OG00495
Title
Denominators
Categories
Baseline
Title
Measurements
OG000471.8± 219.7
OG001510.9± 295.1
OG002487.1± 255.1
OG003442.8± 247.3
OG004501.3± 302.9
Week 24
Title
Measurements
OG000449.2± 195.8
OG001479.7± 327.7
OG002460.4± 213.5
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.481
Mean Difference (Final Values)
22.5
2-Sided
95
-40.2
85.2
No
Superiority or Other
OG000
OG002
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.894
Mean Difference (Final Values)
4.2
2-Sided
95
-57.5
65.9
No
Superiority or Other
OG000
OG003
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.991
Mean Difference (Final Values)
-0.3
2-Sided
95
-61.5
60.8
No
Superiority or Other
OG000
OG004
Analysis of adjusted difference in change from baseline.
Mixed Models Analysis
Mixed Model with repeated measures: change = MMSE Japan baseline baseline * visit visit treatment treatment * visit.
0.422
Mean Difference (Final Values)
-25.5
2-Sided
95
-87.9
36.9
No
Superiority or Other
OG002
SAM-531 (3.0 mg)
SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG003
SAM-531 (5.0 mg)
SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.
OG004
Donepezil
Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator's discretion.