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CompletedPhase 3

A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease

Lead sponsor

Eisai Limited

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

260

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 1-12

Primary endpoint

•The total Severe Impairment Battery (SIB) score

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 IDE2020-C086-339

NCT IDNCT01404169

Timeline

Milestones

Study first posted2011-07-27estimated

Study start2011-09actual (month precision)

Primary completion2014-07actual (month precision)

Study completion2014-09actual (month precision)

Last update posted2017-03-08actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Written informed consent (IC) will be obtained from the subject (if possible) or from the subject's legal guardian or legal representative prior to beginning screening activities.

•Subject age range: male and female subjects 50 to 90 years of age, inclusive

•Diagnosis: diagnostic evidence of probable Alzheimer's Disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

•MMSE 1 to 12 inclusive, at both Screening and Baseline

•SIB less than or equal to 90 and greater than or equal to 10 at both Screening and Baseline

•Comorbid medical conditions must be clinically stable prior to Baseline, unless otherwise specified

Exclusion criteria

•Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD

•Evidence of focal disease to account for dementia on any cranial image MRI or CT.

•Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria

•Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed

•Illiteracy prior to AD

•Subjects who are unwilling or unable to fulfill the requirements of the study

•Treatment with another cholinesterase inhibitor and/or memantine in the 3 months prior to Screening

•Subjects with a poor response (tolerability) to prior exposure to donepezil

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.

Global cognition

2 endpoints

Primary/protocol endpoint

The change in the total Severe Impairment Battery (SIB) score at Week 24

Time frame:24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24

Time frame:24 weeks

change from baseline, improvement

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.