ELND005 Long-Term Follow-up Study in Subjects With Alzhei... | NCT00934050 | Trialant
NCT00934050
Sponsor
OPKO Health, Inc.
Status
Completed
Last Update Posted
Oct 21, 2019Actual
Enrollment
103Actual
Phase
Phase 2
Conditions
Alzheimer's Disease
Interventions
ELND005 (scyllo-inositol)
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT00934050
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
ELND005-AD251
Secondary IDs
Not provided
Brief Title
ELND005 Long-Term Follow-up Study in Subjects With Alzheimer's Disease
Official Title
A Long-Term Follow-Up Study of Oral ELND005 (AZD-103) in Subjects With Alzheimer's Disease
Acronym
Not provided
Organization
OPKO Health, Inc.INDUSTRY
Status Module
Record Verification Date
Oct 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jun 2009
Primary Completion Date
Jun 2011Actual
Completion Date
Jun 2011Actual
First Submitted Date
Jun 29, 2009
First Submission Date that Met QC Criteria
Jul 6, 2009
First Posted Date
Jul 8, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 22, 2015
Results First Submitted that Met QC Criteria
May 12, 2015
Results First Posted Date
May 13, 2015Estimated
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
Oct 17, 2019
Last Update Posted Date
Oct 21, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
OPKO Health, Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 purpose of this study is to evaluate the long-term safety and tolerability of ELND005 beyond the 18 months of treatment in original randomized and blinded clinical trail ELND005-AD201.
Detailed Description
Not provided
Conditions Module
Conditions
Alzheimer's 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
103Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
ELND005
Experimental
Drug: ELND005 (scyllo-inositol)
Interventions
Name
Type
Description
Arm Group Labels
Other Names
ELND005 (scyllo-inositol)
Drug
Prior to 15Dec2009: ELND005 2000 mg PO BID for 48 weeks
After 15Dec2009: ELND005 250 mg PO BID for 48 weeks
ELND005
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Treatment Emergent Adverse Events (TEAEs)
Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)
12 months
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
This study is open only to subjects who have completed the week 78 visit in Study ELND005-AD201 while taking their assigned dose of study drug medication.
Exclusion Criteria:
Subject has no new medical contraindications to continued participation in the study.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
Not provided
Maximum Age
Not provided
Standard Ages
ChildAdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Banner Alzheimer's Institute
Phoenix
Arizona
85006
United States
Sun Health Research Institute
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
All participants who enrolled in long term follow up prior to 15 Dec 2009 received ELND005 2000 mg BID; due to protocol amendment, all participants who enrolled in long term follow up after 15 Dec 2009 received ELND005 250 mg BID
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo/ELND005 2000mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
FG001
Periods
Title
Milestones
Reasons Not Completed
Enrolled Prior to 15 Dec 2009
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
Not provided
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
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
scyllo-inositol
Sun City
Arizona
85351
United States
University of Arizona, Health Sciences Center, Dept. of Neurology
Tucson
Arizona
85724
United States
Margolin Brain Institute
Fresno
California
93720
United States
Collaborative NeuroScience Network, Inc.
Garden Grove
California
92845
United States
Yale University School of Medicine, Alzheimer's Disease Research Unit
New Haven
Connecticut
06510
United States
Brain Matters Research
Delray Beach
Florida
33445
United States
Sunrise Clinical Research, Inc
Hollywood
Florida
33021
United States
Roskamp Institute
Sarasota
Florida
34243
United States
Premiere Research Institute
West Palm Beach
Florida
33407
United States
Emory University, Dept. of Neurology
Atlanta
Georgia
30329
United States
Dekalb Neurology Associates, LLC
Decatur
Georgia
30033
United States
Department of Neurology - Indiana University Medical Center
Indianapolis
Indiana
46202
United States
University of Kansas Medical Center, Department of Neurology
Kansas City
Kansas
66160
United States
Innovative Clinical Concepts
Paducah
Kentucky
42003
United States
Memory Enhancement Center of America, Inc.
Eatontown
New Jersey
07724
United States
Global Medical Institutes
Princeton
New Jersey
08540
United States
Albuquerque Neuroscience, Inc.
Albuquerque
New Mexico
87109
United States
Neurological Associates of Albany, PC
Albany
New York
12208
United States
Columbia University Sergievsky Center
New York
New York
10032
United States
AD-CARE, Monroe Community Hospital
Rochester
New York
14620
United States
Raleigh Neurology Associates
Raleigh
North Carolina
27607
United States
Neurology & Neuroscience Center of Ohio
Toledo
Ohio
43623
United States
Medford Neurological and Spine Clinic
Medford
Oregon
97504
United States
Summit Research Newtwork, Inc.
Portland
Oregon
97210
United States
The Clinical Trial Center, LLC
Jenkintown
Pennsylvania
19046
United States
University of Pittsburgh Alzheimer Disease Research Clinic
Pittsburgh
Pennsylvania
15213
United States
Butler Hospital, Memory and Aging Center
Providence
Rhode Island
02906
United States
Alliance for Neuro Research, LLC dba Absher Neurology, PA
Greenville
South Carolina
29615
United States
Clinical Neuroscience Research Associates, Inc-The Memory Clinic
Bennington
Vermont
05201
United States
Glenrose Rehabilitation Hospital
Edmonton
Alberta
T5G 0B7
Canada
University of British Columbia Hospital, Division of Neurology
Vancouver
British Columbia
V6T 2B5
Canada
Parkwood Hospital
London
Ontario
N6C 5J1
Canada
Sisters of Charity of Ottawa Health Service
Ottawa
Ontario
K1N 5C8
Canada
Kawartha Regional Memory Clinic
Peterborough
Ontario
K9H 2P4
Canada
Whitby Mental Health Memory Clinic
Toronto
Ontario
M5T 2S8
Canada
Gerontion Research, Inc.
Toronto
Ontario
M6M 3Z5
Canada
Recherche Clinique de Neurologie (Hospital Maisonneuve Rosemont)
Montreal
Quebec
H1T 2M4
Canada
250mg/ELND005 2000mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
FG002
1000 mg/ELND005 2000 mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
FG003
2000 mg ELND005/ELND005 2000 mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
FG004
Placebo/ELND005 250 mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
FG005
250 mg/ELND005 250 mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
FG00012 subjects
FG00112 subjects
FG00212 subjects
FG00314 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG00012 subjects
FG00112 subjects
FG00212 subjects
FG00314 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
Sponsor Decision
FG00011 subjects
FG00112 subjects
FG00211 subjects
FG00313 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Enrolled After 15 Dec 2009
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG00426 subjects
FG00527 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo/2000mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
BG001
250mg BID/2000 mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
BG002
1000mg BID/2000mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
BG003
2000mg BID/2000mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND05 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
BG004
Placebo/ELND005 250mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
BG005
250 mg/ELND005 250 mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00012
BG00112
BG00212
BG00314
BG00426
BG00527
BG006103
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Enrolled prior to 15 Dec 2009
Title
Measurements
BG00076.8± 5.51
BG00177.0± 6.98
BG00276.9± 6.92
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0015
BG002
Race/Ethnicity, Customized
Number
participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0001
BG0010
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
North America
Title
Measurements
BG00012
BG00112
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
Treatment Emergent Adverse Events (TEAEs)
Safety and Tolerability was assessed by the incidence of Treatment Emergent Adverse Events (TEAEs)
As a result of safety findings, effective 15 December 2009, all 50 patients at the 2000 mg BID dose were withdrawn from the study. Subsequently patients who were on placebo or 250 mg BID in Study AD201 received 250 mg BID in Study AD251. Only Arms who completed the study per the protocol were included in the analysis.
Posted
Number
participants
12 months
ID
Title
Description
OG000
Placebo/ELND005 250mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
OG001
250 mg/ELND005 250 mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
Units
Counts
Participants
OG00026
OG00127
Title
Denominators
Categories
Title
Measurements
OG00021
OG00123
Time Frame
Adverse events were recorded for each patient, starting from the time the consent form was signed until completion of the study (Week 54, Follow-up).
Description
For all adverse event (AE) summaries, if a patient had more than one AE within a preferred term the patient was counted once, at the maximum severity and with the closest relationship to study drug. If a patient had more than one AE within a system organ class (SOC), the patient was similarly counted once when reporting results for that SOC.
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/ELND005 2000mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
1
12
0
12
EG001
250mg/ELND005 2000mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
1
12
0
12
EG002
1000 mg/ELND005 2000 mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
0
12
0
12
EG003
2000 mg ELND005/ELND005 2000 mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
2
14
3
14
EG004
Placebo/ELND005 250 mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
5
26
11
26
EG005
250 mg/ELND005 250 mg BID
In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
6
27
15
27
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial Fibrillation
Cardiac disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG0031 affected14 at risk
EG0040 affected26 at risk
EG0050 affected27 at risk
Cardiac Failure Congestive
Cardiac disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Bradycardia
Cardiac disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Klebsiella Sepsis
Infections and infestations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pneumonia
Infections and infestations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Sepsis
Infections and infestations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Urinary Tract Infection
Infections and infestations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Femoral Neck Fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Lumbar Vertebral Fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Rib Fracture
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Dehydration
Metabolism and nutrition disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Basal Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Bladder transitional Cell Carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Colon Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systematic Assessment
EG0000 affected12 at risk
EG0011 affected12 at risk
EG0020 affected12 at risk
EG003
Presyncope
Nervous system disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Transient Ischaemic Attack
Nervous system disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Agitation
Psychiatric disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Confusional State
Psychiatric disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Acute Respiratory Failure
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pneumonia Aspiration
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Respiratory Failure
Respiratory, thoracic and mediastinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Hypotension
Vascular disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG0030 affected14 at risk
EG0042 affected26 at risk
EG0052 affected27 at risk
Diarrhoea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Urinary Tract Infection
Infections and infestations
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Fall
Injury, poisoning and procedural complications
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Back Pain
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Pain In Extremity
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Agitation
Psychiatric disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Insomnia
Psychiatric disorders
Systematic Assessment
EG0000 affected12 at risk
EG0010 affected12 at risk
EG0020 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Susan Abushakra, MD, Chief Medical Officer
Transition Therapeutics Ireland Limited and Transition Therapeutics USA Inc.
+1 650 425 6370
susan.abushakra@tthi.us
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
C009217
scyllitol
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
19 subjects
FG00523 subjects
7 subjects
FG0054 subjects
0 subjects
FG0043 subjects
FG0050 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0044 subjects
FG0052 subjects
69.2
± 8.51
BG004NA± NAAll participants enrolled after 15 Dec 2009
BG005NA± NAAll participants enrolled after 15 Dec 2009
BG00674.7± 7.73
Participants enrolled after 15 Dec 2009
Title
Measurements
BG000NA± NAAll participants enrolled prior to 15 Dec 2009
BG001NA± NAAll participants enrolled prior to 15 Dec 2009
BG002NA± NAAll participants enrolled prior to 15 Dec 2009
BG003NA± NAAll participants enrolled prior to 15 Dec 2009