CompletedPhase 3

A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes

A Six-month, Multicenter, Double-blind, Parallel, Placebo-controlled Study of the Effect on Global/Behavioural/ADL Functions and Tolerability of Aricept in Patients Wtih Severe Alzheimer's Disease Living in an Assisted Care Facility

Lead sponsor

Pfizer

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

249

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•ADCS-Activities of Daily Living (ADCS-ADL)•Severe Impairment Battery (SIB) total 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 IDA2501017

NCT IDNCT00630851

Timeline

Milestones

Study start2002-10 (month precision)

Study completion2004-10actual (month precision)

Study first posted2008-03-07estimated

Last update posted2015-03-05estimated

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

•Probable or possible Alzheimer's disease

•Living in skilled nursing home

Exclusion criteria

•Other types of dementia or psychiatric or neurologic disorders

•Musculoskeletal disease

Endpoints (8)

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

Function / daily living

Behavior / neuropsychiatric

Safety / tolerability / PK

Other clinical outcomes

Global cognition

3 endpoints

Primary/protocol endpoint

Change from baseline in Severe Impairment Battery (SIB) total score

Time frame:Month 6

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in SIB total score

Time frame:Month 3

change from baseline, improvement

Secondary/protocol endpoint

Change from inclusion in Mini Mental State Examination (MMSE) total score

Time frame:Month 6

Mini-Mental State Examination (MMSE)

descriptive

Function / daily living

2 endpoints

Primary/protocol endpoint

Change from baseline in modified Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory for Severe Alzheimer's Disease (ADCS-ADL-severe) total score

Time frame:Month 6

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/protocol endpoint

Change from baseline in modified ADCS-ADL-severe total score

Time frame:Month 3

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Change from baseline in Neuropsychiatric Inventory (NPI) total score

Time frame:Months 3 and 6

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Adverse events and laboratory value changes

Time frame:Months 3 and 6

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Change from baseline in Clinical Global Impression of Improvement (CGI-I) score

Time frame:Months 3 and 6

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.