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Sponsored by: |
Pfizer |
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Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00630851 |
The purpose of the study is to evaluate the efficacy and safety of Aricept in nursing home patients with severe Alzheimer's disease.
Condition | Intervention | Phase |
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Alzheimer Disease |
Drug: Donepezil (Aricept) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 280 |
Study Start Date: | October 2002 |
Study Completion Date: | October 2004 |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Donepezil (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
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2: Placebo Comparator |
Drug: Placebo
Matching placebo tablets orally once daily for 6 months
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Pfizer, Inc. ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A2501017 |
Study First Received: | February 27, 2008 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00630851 |
Health Authority: | Sweden: Medicinal Products Agency |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Nootropic Agents Cholinesterase Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Therapeutic Uses Physiological Effects of Drugs |
Nervous System Diseases Enzyme Inhibitors Cholinergic Agents Tauopathies Central Nervous System Agents Pharmacologic Actions |