A Study of Semagacestat for Alzheimer's Patients | NCT01035138

ID	Type	Description	Link
H6L-MC-LFBF	Other Identifier	Eli Lilly and Company

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
Drug: semagacestat	Experimental		Drug: semagacestat

Name	Type	Description	Arm Group Labels	Other Names
semagacestat	Drug	140mg administered orally, once daily for 24 months; dose reduction to 100mg or 60 mg possible due to intolerability	Drug: semagacestat

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug	The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity.	Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug
Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug	The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity.	Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug

Secondary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12	Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.	Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)	Eli Lilly and Company	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.		Phoenix	Arizona	85004

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 milligram (mg) orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
BG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
BG002	LFAN LY 140 mg/LY 140 mg	Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
BG003	Total	Total of all reporting groups

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

Title	Measurements
	BG00074.1± 8.3 BG00173.5± 8.7 BG00274.1± 9.5 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00039 BG00133 BG002

Race/Ethnicity, Customized

Number

participants

Title

Denominators

Categories

White

Title	Measurements
	BG00061 BG00158 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00040 BG00138 BG002

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11)

The cognitive subscale of the ADAS (ADAS-Cog11) was used as a primary efficacy measure and consisted of 11 items assessing areas of function most typically impaired in AD: orientation, verbal memory, language, and praxis. The scale ranged from 0-70, with higher scores indicating greater disease severity.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00021.0± 8.5 BG001

Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)

The ADCS-ADL was a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total ADCS-ADL score ranged from 0-78, with lower scores indicating greater disease severity.

Mean

Standard Deviation

units on a scale

Title

Denominators

Categories

Title	Measurements
	BG00063.7± 11.4 BG001

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 Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 16 After Cessation of Study Drug

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Mean

Standard Deviation

units on a scale

Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002	LFAN LY 140 mg/LY 140 mg	Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study

Units	Counts
Participants	OG00041 OG00140 OG00226

Title

Denominators

Categories

Title	Measurements
	OG0006.4± 11.53 OG00112.5± 12.82 OG00210.5± 13.62

Primary

Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 16 After Cessation of Study Drug

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Mean

Standard Deviation

units on a scale

Baseline (LFAN randomization), 16 weeks (LFBF) after cessation of study drug

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002	LFAN LY 140 mg/LY 140 mg

Secondary

Percent Change From Baseline in Amyloid Beta (Aβ) 1-42 Plasma Concentration at Week 12

Concentration of amino acid peptide known as Aβ 1-42 in plasma. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Least Squares Mean

Standard Error

percentage of change

Baseline (LFAN Randomization ), 6 hours pose-dose at Week 12 (LFBF)

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002	LFAN LY 140 mg/LY 140 mg	Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study

Secondary

Change From Baseline in Hippocampal Volume Using Volumetric Magnetic Resonance Imaging (vMRI) at Week 12

The vMRI assessment of right hippocampal and left hippocampal volume is reported. Least Square (LS) Mean value was controlled for baseline value, age, and investigator.

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Least Squares Mean

Standard Error

cubic millimeter (mm³)

Baseline (LFAN Randomization), 12 weeks (LFBF)

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002	LFAN LY 140 mg/LY 140 mg	Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study

Secondary

Change From Baseline in Amyloid Imaging Positron Emission Tomography (AV-45-PET) at Week 12

A radioactive tracer for PET that is a ligand for amyloid called [18F]-AV-45. This permits the visualization of amyloid in the brains of Alzheimer's participants. The outcome reported is the composite summary of the standard uptake value ratio for the cerebellar gray matter. Least Squares (LS) Mean value was controlled for baseline value, age, and investigator. Due to insufficient sample size, this analysis was not done.

Due to insufficient sample size, this analysis was not done.

Baseline (LFAN Randomization), 12 weeks (LFBF)

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002	LFAN LY 140 mg/LY 140 mg	Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study

Secondary

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog11) at Week 12

The cognitive subscale of the ADAS (ADAS-Cog11) consists of 11 items assessing areas of function most typically impaired in Alzheimer's Disease (AD): orientation, verbal memory, language, and praxis. The scale ranges from 0 to 70, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Least Squares Mean

Standard Error

units on a scale

Baseline (LFAN Randomization), 12 weeks (LFBF)

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002	LFAN LY 140 mg/LY 140 mg

Secondary

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 12

ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Least Squares Mean

Standard Error

units on a scale

Baseline (LFAN Randomization), 12 weeks (LFBF)

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during Study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002	LFAN LY 140 mg/LY 140 mg

Secondary

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 12

The ADAS-Cog14 is the ADAS-Cog11 augmented with delayed free recall, digit cancellation, and maze completion measures. A score of 0 to 10 for delayed free recall and a conversion code of 0 to 5 for digit cancellation and maze completion provide total score ranges for this extended ADAS-Cog14 of 0 to 90. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, and concomitant standard of care (SOC) medication.

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Least Squares Mean

Standard Error

units on a scale

Baseline (LFAN Randomization), 12 weeks (LFBF)

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during Study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study

Secondary

Change From Baseline in Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL) at Week 12

The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. It measures both basic and instrumental activities of daily living. The total score ranges from 0 to 78, with lower scores indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Least Squares Mean

Standard Error

units on a scale

Baseline (LFAN Randomization), 12 weeks (LFBF)

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002

Secondary

Mean Concentration of LY450139

Participants who completed Study LFAN, took study drug in extension study and had pharmacokinetics measurements.

Geometric Mean

Geometric Coefficient of Variation

nanogram/milliliter (ng/mL)

3 months (pre-dose, 2, 4, and 6 hours after dosing )(LFBF)

ID	Title	Description
OG000	LY 140 mg	Participants received 140 mg LY450319 orally once daily up to 24 months during extension study (LFBF)

Units	Counts
Participants	OG00046

Secondary

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog12) at Week 16 After Cessation of Study Drug

ADAS-Cog12 is the ADAS-Cog11 augmented with the delayed free recall measure, resulting in a total score ranging from 0 to 80. Higher scores indicate greater disease severity.

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Mean

Standard Deviation

units on a scale

Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002	LFAN LY 140 mg/LY 140 mg	Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study

Secondary

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog14) at Week 16 After Cessation of Study Drug

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Mean

Standard Deviation

units on a scale

Baseline (LFAN Randomization), 16 weeks (LFBF) after cessation of study drug

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002	LFAN LY 140 mg/LY 140 mg

Secondary

Change From Baseline in Clinical Dementia Rating Scale (Sum of Boxes) (CDR-SB) at Week 24

The CDR-SB is a semi-structured interview of participants and their caregivers. The participant's cognitive status is rated in 6 domains of functioning, including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. A severity score is assigned for each of the 6 domains with total score ranging from 0 to 18. Higher scores indicate greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Least Squares Mean

Standard Error

units on a scale

Baseline (LFAN Randomization), 24 weeks (LFBF)

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study

Secondary

Change From Baseline in Mini-Mental State Examination (MMSE) at Week 24

The MMSE is a brief screening instrument used to assess cognitive function in elderly participants. It assesses orientation, memory, attention, and ability to name objects, follow verbal and written commands, write a sentence, and copy figures. The total score ranges from 0 to 30, with a lower score indicating greater disease severity. Least Square (LS) Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Least Squares Mean

Standard Error

units on a scale

Baseline (LFAN Randomization), 24 weeks (LFBF)

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002

Secondary

Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 24

The NPI is a tool for assessing psychopathology in patients with dementia and other neurologic disorders. Information is obtained from a caregiver familiar with the patient's behavior. The score ranges from 12 to 144, with higher scores indicating greater disease severity. Least Square (LS) Mean value was controlled for the baseline value, age, investigator, concomitant standard of care medication.

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Least Squares Mean

Standard Error

units on a scale

Baseline (LFAN Randomization), 24 weeks (LFBF)

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002	LFAN LY 140 mg/LY 140 mg

Secondary

Change From Baseline in EuroQol-5D (EQ-5D) at Week 24

EQ-5D (proxy version) measures mobility, self-care, usual activities, pain/discomfort, anxiety/depression; each has 3 severity levels (no, some, severe problems) coded to a 1-digit number (1-3). Digits are combined into 5-digit number describing health state. Numbers 1-3 are not added for total score. Visual Analog Scale (VAS) assesses caregiver's impression of participant's overall health state; VAS scores range=0-100, with lower scores indicating greater disease severity. LS Mean value was controlled for baseline value, age, investigator, and concomitant standard of care (SOC) medication.

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Least Squares Mean

Standard Error

units on a scale

Baseline (LFAN Randomization), 24 weeks (LFBF)

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study

Secondary

Change From Baseline in Resource Utilization in Dementia-Lite Questionnaire (RUD-Lite) at Week 12

RUD-Lite assesses the healthcare resource utilization of participants and their caregivers to determine the level of formal and informal care attributable to Alzheimer's Disease (AD). Information on both caregivers (caregiving time, work status) and participants (accommodation and healthcare resource utilization) is collected from the baseline and follow-up interviews. Reported the change in number of hospitalizations per participant to week 12.

Participants who completed Study LFAN, took at least one dose of study drug in extension study and had both baseline and post-baseline values.

Mean

Standard Deviation

number of hospitalizations

Baseline (LFAN Randomization), 12 weeks (LFBF)

ID	Title	Description
OG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
OG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
OG002

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	LFAN Placebo/LY140 mg	Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)	6	73	5	73
EG001	LFAN LY 100 mg/ LY 140 mg	Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study	4	60	3	60
EG002	LFAN LY 140 mg/LY 140 mg	Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study	2	47	4	47

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected60 at risk EG0020 events0 affected47 at risk
Cholecystitis Acute	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0002 events1 affected73 at risk EG0010 events0 affected60 at risk EG0020 events0 affected47 at risk
Hepatic Cyst Ruptured	Hepatobiliary disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected60 at risk EG0020 events0 affected47 at risk
Femur Fracture	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected60 at risk EG0020 events0 affected47 at risk
Spinal Column Stenosis	Musculoskeletal and connective tissue disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected60 at risk EG0021 events1 affected47 at risk
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected60 at risk EG0020 events0 affected47 at risk
Squamous Cell Carcinoma Of Skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected60 at risk EG0020 events0 affected47 at risk
Ischaemic Stroke	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected60 at risk EG0020 events0 affected47 at risk
Syncope	Nervous system disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected60 at risk EG0020 events0 affected47 at risk
Aggression	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected73 at risk EG0010 events0 affected60 at risk EG0021 events1 affected47 at risk
Anxiety	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0000 events0 affected73 at risk EG0011 events1 affected60 at risk EG0020 events0 affected47 at risk
Confusional State	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected60 at risk EG0020 events0 affected47 at risk
Mania	Psychiatric disorders	MedDRA 13.1	Systematic Assessment	EG0001 events1 affected73 at risk EG0010 events0 affected60 at risk EG0020 events0 affected47 at risk

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

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Contusion	Injury, poisoning and procedural complications	MedDRA 13.1	Systematic Assessment		EG0001 events1 affected73 at risk EG0012 events2 affected60 at risk EG0023 events3 affected47 at risk
Hair Colour Changes	Skin and subcutaneous tissue disorders	MedDRA 13.1	Systematic Assessment		EG0004 events4 affected73 at risk EG0011 events1 affected60 at risk EG0021 events1 affected47 at risk