← Trials/Trial dossier/NCT00467766

CompletedPhase NA

Combining a Caregiver Intervention With Aricept Treatment for Mild to Moderate Alzheimer's Disease

Lead sponsor

Pfizer

Asset

Donepezil

Listed sites

Recruiting sites

Enrollment

300

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Alzheimer's disease

Primary endpoints

•Caregiver•ADAS-Cog•ADCS-Activities of Daily Living (ADCS-ADL)

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 IDIA0114

NCT IDNCT00467766

Timeline

Milestones

Study start1999-07 (month precision)

Study completion2003-06actual (month precision)

Study first posted2007-05-01estimated

Last update posted2007-05-07estimated

Assets

Drug assets

Donepezil

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age21 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Individuals diagnosed with mild to moderate stage Alzheimer's disease and their spouse caregivers

Exclusion criteria

•Severe psychological or physical illness

•Unwillingness by either spouse to participate in all aspects of the study

Endpoints (6)

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

Behavior / neuropsychiatric

Global cognition

Function / daily living

Disease progression

Caregiver / quality of life

Global cognition

1 endpoint

Primary/protocol endpoint

Patient: Changes in cognition measured by ADAS-cog

Time frame:every 3 months for the first year, and every 6 months for the second year

ADAS-Cog

descriptive

Function / daily living

1 endpoint

Primary/protocol endpoint

Patient: Changes in abilities with activities of daily living measured by ADCS-ADL

Time frame:every 3 months for the first year, and every 6 months for the second year

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

2 endpoints

Primary/protocol endpoint

Caregiver: Changes in depression, measured with the Beck Depression Inventory

Time frame:every 3 months for the first year, and every 6 months for the second year

descriptive

Secondary/protocol endpoint

Caregiver: Changes in reactions to patient behavior, physical health, family conflict and sense of mastery

Time frame:every 3 months for the first year, and every 6 months for the second year

descriptive

Disease progression

1 endpoint

Secondary/protocol endpoint

Patient: Time to nursing home placement

time to event, event

Caregiver / quality of life

1 endpoint

Primary/protocol endpoint

Caregiver: Changes in social support satisfaction, measured with the Stokes Social Network Scale

Time frame:every 3 months for the first year, and every 6 months for the second year

descriptive

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.