CompletedPhase 1Results posted

A Study to Test the Performance of the CogState Computerized Neuropsychological Battery in Patients With Alzheimer's Disease (0000-086)(COMPLETED)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial, With Placebo Run-In, and an Open-Label Treatment Period, to Evaluate the Performance of the CogState Computerized Neuropsychological Battery and the ADAS-Cog in Generally Cholinesterase-naive AD Patients

Lead sponsor

Merck Sharp & Dohme LLC

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

106

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Study partner/caregiver required

Primary endpoint

•Mean Computer-based Cognitive Assessment (CogState) Composite Score

Identifiers

Registered as

Org study ID0000-086

Secondary2008_573

NCT IDNCT00777608

Timeline

Milestones

Study first posted2008-10-22estimated

Study start2008-12 (month precision)

Primary completion2009-10actual (month precision)

Study completion2010-04actual (month precision)

Results first posted2011-02-24estimated

Last update posted2015-08-25estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participant is ambulatory, male or female and 55 years of age or older

•Participant has reliable informant/caregiver who can communicate effectively with the study site and personnel

Exclusion criteria

•Participant has a history within the last 6 months or current evidence of a psychotic disorder or an active major depressive disorder or participant has any history of schizophrenia

•Participant has a history of multiple and/or serious allergies to drugs or food or a history of an allergic reaction to more than 3 drug classes

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Memory

Global cognition

4 endpoints

Primary/protocol endpoint

Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4

Time frame:Baseline and 4 weeks

change from baseline, improvement

Primary/registry result

Change in Mean Computer-based Cognitive Assessment (CogState) Composite Score at Week 4

Time frame:Baseline and 4 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Donepezil 5-10 mgn=38 Participants	-0.10	0.07
Placebon=43 Participants	-0.07	0.06

Mean Difference (Final Values)-0.0790% CI-0.2 - 0.08p0.231ANOVA

Secondary/protocol endpoint

Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12

Time frame:Baseline and 4 weeks, 8 weeks and 12 weeks.

ADAS-Cog

change from baseline, improvement

Secondary/registry result

Evaluate the Efficacy of Donepezil by Determining the Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Score at Week 4, Week 8 and Week 12

Time frame:Baseline and 4 weeks, 8 weeks and 12 weeks.

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Donepezil 5-10 mgWeek 4 (N=38, N=43)n=38 Participants	0.2	0.8
Week 8 (N=37, N=40)n=38 Participants	0.07	1.0
Week 12 (N=38, N=40)n=38 Participants	-1.4	1.0
PlaceboWeek 4 (N=38, N=43)n=43 Participants	-0.3	0.7
Week 8 (N=37, N=40)n=43 Participants	-0.7	1.0
Week 12 (N=38, N=40)n=43 Participants	-1.0	1.0

Mean Difference (Final Values)0.590% CI-1.2 - 2.2p0.324ANOVA

Mean Difference (Final Values)0.890% CI-1.5 - 3.1p0.285ANOVA

Mean Difference (Final Values)-0.390% CI-2.6 - 1.9p0.401ANOVA

Memory

2 endpoints

Secondary/protocol endpoint

Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12

Time frame:Baseline and 2 weeks, 8 weeks and 12 weeks

change from baseline, improvement

Secondary/registry result

Evaluate the Efficacy of Donepezil by Determining the Change in Mean CogState Composite Score at Week 2, Week 8 and Week 12

Time frame:Baseline and 2 weeks, 8 weeks and 12 weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Score on a scale	Standard error
Donepezil 5-10 mgWeek 2 (N=38, N=43)n=38 Participants	-0.2	0.07
Week 8 (N=38, N=40)n=38 Participants	-0.1	0.07
Week 12 (N=38, N=41)n=38 Participants	-0.2	0.07
PlaceboWeek 2 (N=38, N=43)n=43 Participants	-0.006	0.06
Week 8 (N=38, N=40)n=43 Participants	-0.02	0.07
Week 12 (N=38, N=41)n=43 Participants	-0.09	0.07

Mean Difference (Final Values)-0.290% CI-0.3 - -0.008p0.041ANOVA

Mean Difference (Final Values)-0.190% CI-0.3 - 0.06p0.143ANOVA

Mean Difference (Final Values)-0.0790% CI-0.2 - 0.09p0.226ANOVA

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.