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CompletedPhase 2Results posted

Computerized Cognition Testing in Participants With Mild Alzheimer's Disease (AD) Treated With Donepezil (MK-0000-318)

A Clinical Trial to Assess Cognitive Function by Repeated Computerized Testing in Patients With Mild Alzheimer's Disease Treated With Donepezil

Lead sponsor

Merck Sharp & Dohme LLC

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•Study partner/caregiver required

Primary endpoint

•One-card Learning (OCL) Measurement

Identifiers

Registered as

Org study ID0000-318

NCT IDNCT02064920

Timeline

Milestones

Study first posted2014-02-17estimated

Study start2014-04-22actual

Primary completion2016-07-13actual

Study completion2016-07-13actual

Results first posted2017-08-01actual

Last update posted2018-10-12actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Meets listed criteria for a diagnosis of probable AD

•Has a clearly documented history either in medical records or from an informant of cognitive decline over at least 6 months

•Has a reliable partner/caregiver who is willing to provide input by participating in assessments

•Has results of a physical examination and clinical laboratory tests within normal or clinically acceptable limits

•Can communicate with trial staff acceptably, possesses the ability to respond verbally to questions, follow instructions, complete questionnaires, and adhere to visit schedules

•Can read at a 9th grade level or equivalent, and has an acceptable history of academic achievement and/or employment

•Has a magnetic resonance imaging (MRI) scan that rules out non-AD conditions contributing to cognitive dysfunction

•Capably performs the CogState screening battery

•Has adequate visual acuity and function

•Females are not of childbearing potential

Exclusion criteria

•Has ever received acetylcholinesterase inhibitors, memantine, or other symptomatic AD treatment including approved medical foods

•Has an uncontrolled, clinically significant medical condition or situation within 3 months prior to screening

•Has had major surgery within 3 months prior to screening

•Has tested positive for human immunodeficiency virus (HIV) or has evidence of an active hepatitis B infection

•Has a history of malignancy within the prior 5 years

•Is unwilling or ineligible to undergo an MRI scan

•Has a history of clinically important structural changes on screening MRI scan

•Has a clinically important history of stroke or a diagnosis of vascular dementia

•Has evidence of a clinically relevant non-AD neurological disorder

•Has a history of head trauma, or serious infectious disease affecting the brain within the prior 3-5 years

•Has evidence of a clinically relevant or unstable psychiatric disorder, excepting major depression in remission

•Has evidence of a current episode of major depression

•Has evidence of Type 4 or Type 5 Suicidal Ideation

•Has clinically significant vitamin B12 or folate deficiency in the 6 months prior to screening

•Is pregnant, attempting to become pregnant or is nursing children

•Has used any investigational drug or participated in any other clinical trial within the prior 30 days

•Has a history of alcoholism or drug dependency/abuse within the last 5 years

•Has a relative contraindication to donepezil including sick sinus syndrome, third degree heart block, active gastrointestinal (GI) bleeding, Zollinger-Ellison syndrome, uncontrolled peptic ulcer disease, or uncontrolled asthma

Endpoints (4)

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.

Memory

4 endpoints

Primary/protocol endpoint

One-card Learning (OCL) Measurement Over 12 Weeks of Treatment

Time frame:Weeks 4, 8, 12 and 16

threshold achievement, improvement

Primary/registry result

One-card Learning (OCL) Measurement Over 12 Weeks of Treatment

Time frame:Weeks 4, 8, 12 and 16

threshold achievement, improvement

Posted result

Group	Value (mean), Score on a scale	Standard deviation
PlaceboWeek 4 (n = 5, 28)n=5 Participants	0.954	0.091
Week 8 (n = 5, 22)n=5 Participants	0.822	0.179
Week 12 (n = 5, 21)n=5 Participants	0.849	0.132
Week 16 (n = 5, 21)n=5 Participants	0.961	0.123
DonepezilWeek 4 (n = 5, 28)n=28 Participants	0.942	0.112
Week 8 (n = 5, 22)n=28 Participants	0.969	0.104
Week 12 (n = 5, 21)n=28 Participants	0.984	0.118
Week 16 (n = 5, 21)n=28 Participants	0.993	0.112

Change in SD from Week 4 to Week 160.00595% CI-0.031 - 0.039

Change from Week 4 to Week 16 in Standard Deviation (SD) of OCL for Placebo + Donezepil treatment groups combined

Secondary/protocol endpoint

Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment

Time frame:Weeks 4, 8, 12 and 16

threshold achievement, improvement

Secondary/registry result

Percentage of Correct Responses in the OCL Task Over 12 Weeks of Treatment

Time frame:Weeks 4, 8, 12 and 16

threshold achievement, improvement

Posted result

Group	Value (mean), Percentage of Corrrect Responses	Standard deviation
PlaceboWeek 4 (n = 5, 28)n=5 Participants	66.2	8.3
Week 8 (n = 5, 22)n=5 Participants	53.7	17.1
Week 12 (n = 5, 21)n=5 Participants	56.1	12.7
Week 16 (n = 5, 21)n=5 Participants	66.7	11.6
DonepezilWeek 4 (n = 5, 28)n=28 Participants	64.9	10.3
Week 8 (n = 5, 22)n=28 Participants	67.4	9.5
Week 12 (n = 5, 21)n=28 Participants	68.6	10.4
Week 16 (n = 5, 21)n=28 Participants	69.5	9.8

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.