CompletedPhase NA

A Randomized, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil in Subjects With MCI

A Randomized Double-Blind, Parallel, Placebo-Controlled Trial to Examine the Efficacy of Oral Donepezil (5 mg QD for 6 Weeks) After Single Dose and Steady State Therapy (2 Weeks and 6 Weeks) in Subjects With Mild Cognitive Impairment

Lead sponsor

Pfizer

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•MMSE 24-30

Primary endpoints

•ADAS-Cog•MRS profile

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDA9001134

NCT IDNCT00483028

Timeline

Milestones

Study start2004-06 (month precision)

Study completion2007-01actual (month precision)

Study first posted2007-06-06estimated

Last update posted2008-02-05estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Healthy males or females ages 55-90 inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead ECG and clinical laboratory tests)

•Body Mass Index (BMI) between 18 to 34 kg/m2, inclusive; and a total body weight

•Subjects with mild cognitive impairment (MCI) must have a reliable informant who has an average of 10 hours per week or more contact with the subject.

•Memory complaints and memory difficulties, which are verified by an informant

•Mini-mental status exam (MMSE) score of 24-30

Exclusion criteria

•Subjects with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives

•Insulin-requiring diabetes or uncontrolled diabetes mellitus

•Subjects with a current diagnosis of depression or other psychiatric illnesses

Endpoints (2)

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

Neuroimaging

Global cognition

1 endpoint

Primary/protocol endpoint

Neuropsychologic test scores: GMLT, DSST, Cog State TM including PAL test, RAVLT, ADAS-cog at baseline (pre-dose) 5 and 8 hours after the first dose and 2 and 6 weeks. (Continues in next bullet.)

ADAS-Cog

descriptive

Neuroimaging

1 endpoint

Primary/protocol endpoint

MRS (Magnetic Resonance Spectroscopy) profile including but not limited to NAA (N-acetyl-aspartate), NAA/Cr (N-acetyl-aspartate/creatinine ratio), MI (Myoinositol) and MI/Cr (Myoinositol/creatinine ratio).

ratio, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

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.