A Study of the Efficacy and Safety of Aricept in Patients With Severe Alzheimer's Disease Who Are Living in Skilled Nursing Homes
- Registration Number
- NCT00630851
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 249
Inclusion Criteria
- Probable or possible Alzheimer's disease
- Living in skilled nursing home
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Exclusion Criteria
- Other types of dementia or psychiatric or neurologic disorders
- Musculoskeletal disease
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Donepezil (Aricept) - 2 Placebo -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Change from baseline in Neuropsychiatric Inventory (NPI) total score Months 3 and 6 Change from inclusion in Mini Mental State Examination (MMSE) total score Month 6 Change from baseline in modified ADCS-ADL-severe total score Month 3 Change from baseline in SIB total score Month 3 Change from baseline in Clinical Global Impression of Improvement (CGI-I) score Months 3 and 6 Adverse events and laboratory value changes Months 3 and 6
Trial Locations
- Locations (1)
Pfizer Investigational Site