CompletedPhase 3

Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease

A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period

Lead sponsor

Eisai Inc.

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

229

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥50

Primary endpoint

•Assessments of global and cognitive function of Severe AD patients

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-A001-315

NCT IDNCT00096473

Timeline

Milestones

Study start2001-01 (month precision)

Study first posted2004-11-10estimated

Primary completion2005-06actual (month precision)

Study completion2005-09actual (month precision)

Last update posted2011-04-01estimated

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

•Clinically diagnosed Alzheimer's Disease with MMSE score 1~12

•Have not been treated by any medication for Alzheimer's Disease in past 3 months

•Live in community or Assisted Living Facility

•Healthy or with chronic diseases that are medically controlled or stabilized

•Able to swallow tablets

Exclusion criteria

•Any primary neurological or psychiatric diagnosis (including depressive disorder) other than Alzheimer's Disease

•Dementia caused by organic diseases other than Alzheimer's Disease

Endpoints (3)

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

Behavior / neuropsychiatric

Caregiver / quality of life

Global cognition

1 endpoint

Primary/protocol endpoint

Assessments of global and cognitive function of Severe AD patients

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Assessment of behavior and performance on Activity of Daily Living in severe AD patients

descriptive

Caregiver / quality of life

1 endpoint

Secondary/protocol endpoint

Assessment of caregiver burden

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.