CompletedPhase 3

Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

Randomized, Multicenter, Double-blind, Double-dummy, Parallel-Group Study With an Open-label Extension Phase to Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

Lead sponsor

Eisai Co., Ltd.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

351

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 1-12•Study partner/caregiver required

Primary endpoints

•Severe Impairment Battery (SIB)•Clinician's Interview-Based Impression of Change

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-J081-343

NCT IDNCT01539031

Timeline

Milestones

Study first posted2012-02-27estimated

Study start2012-03 (month precision)

Primary completion2015-01actual (month precision)

Study completion2015-03actual (month precision)

Last update posted2023-06-18actual

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Diagnosis: diagnostic evidence of probable Alzheimer's disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) 290.00 or 290.10

•Mini Mental State Examination (MMSE) less than or equal to 12 and greater than or equal to1 inclusive, at Screening

•SIB less than or equal to 90 and greater than or equal to10 at both Screening and Baseline

•No evidence of focal disease to account for dementia on any cranial image (magnetic resonance imaging [MRI] or computed tomography [CT]).

•Subject age range: male and female subjects greater than or equal to 50 years of age inclusive

•Outpatients (patients in nursing homes are eligible)

•The subject must have a caregiver who will provide informed consent separately for his/her own participation in the study, who will have regular contact with the subject.

•Stable donepezil dose of 10 mg, taken as a single, daily dose for greater than or equal to 3 months prior to the Screening visit

•Subjects who can swallow hole tablets, as tablets should not be broken or crushed

•Comorbid medical conditions must be clinically stable prior to Screening unless otherwise specified.

•Written informed consent will be obtained from the subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities

Exclusion criteria

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

•Subjects with dementia complicated by other organic disease or AD with delirium

•Known hypersensitivity to donepezil or piperidine derivatives, or to any of the excipients in the study drug formulation

•Patients who are expected to live in a nursing home within 24 weeks after randomization (eligible if temporary)

•Use of any prohibited prior or concomitant medications. Memantine will be allowed if taken at prescribed doses that are less than or equal to 20 mg/day, provided that the dose has been stable for at least 6 months prior to Screening.

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

Caregiver / quality of life

Global cognition

1 endpoint

Primary/protocol endpoint

The Severe Impairment Battery (SIB)

Time frame:24 weeks

change from baseline, improvement

Caregiver / quality of life

1 endpoint

Primary/protocol endpoint

The Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC+)

Time frame:24 weeks

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.