The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
249
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
Matching placebo tablets orally once daily for 6 months
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
Change from baseline in Severe Impairment Battery (SIB) total score
Time frame: Month 6
Change from baseline in SIB total score
Time frame: Month 3
Change from baseline in Neuropsychiatric Inventory (NPI) total score
Time frame: Months 3 and 6
Change from inclusion in Mini Mental State Examination (MMSE) total score
Time frame: Month 6
Change from baseline in Clinical Global Impression of Improvement (CGI-I) score
Time frame: Months 3 and 6
Adverse events and laboratory value changes
Time frame: Months 3 and 6
Change from baseline in modified ADCS-ADL-severe total score
Time frame: Month 3
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Pfizer Investigational Site
Fritsla, Sweden, Sweden
Pfizer Investigational Site
Alunda, Sweden
Pfizer Investigational Site
Aneby, Sweden
Pfizer Investigational Site
Avesta, Sweden
Pfizer Investigational Site
Åkersberga, Sweden
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Årsta, Sweden
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Bengtsfors, Sweden
Pfizer Investigational Site
Bergsjö, Sweden
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Boden, Sweden
Pfizer Investigational Site
Borlänge, Sweden
...and 43 more locations