A Phase 3 interventional study of Donepezil (Aricept) and Placebo in Alzheimer Disease, sponsored by Pfizer. Completed at 53 sites in Sweden. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2015-03-05.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.
3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.
This study's enrollment of 249 is above the median of 68 across 2,861 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.
Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Drug: Donepezil (Aricept)
Drug: Placebo
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
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Donepezil