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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00630851

Enrollment

249

Registered

2008-03-07

Start date

2002-10-31

Completion date

2004-10-31

Last updated

2015-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Brief summary

The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.

Interventions

DRUGDonepezil (Aricept)

Donepezil (Aricept) 5 mg tablet orally once daily for 30 days, followed by 10 mg tablet orally once daily to complete 6 months of treatment

DRUGPlacebo

Matching placebo tablets orally once daily for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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	Month 6
Change from baseline in Severe Impairment Battery (SIB) total score	Month 6

Secondary

Measure	Time frame
Change from inclusion in Mini Mental State Examination (MMSE) total score	Month 6
Change from baseline in Clinical Global Impression of Improvement (CGI-I) score	Months 3 and 6
Change from baseline in SIB total score	Month 3
Change from baseline in modified ADCS-ADL-severe total score	Month 3
Adverse events and laboratory value changes	Months 3 and 6
Change from baseline in Neuropsychiatric Inventory (NPI) total score	Months 3 and 6

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026