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Sponsors and Collaborators: |
Eisai Inc. Pfizer |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00571064 |
This is a study to determine the effectiveness and safety of donepezil hydrochloride (E2020) used to treat residents of assisted living facilities diagnosed with mild, moderate, or severe stage Alzheimer's disease.
Condition | Intervention | Phase |
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Mild to Severe Alzheimer's Disease |
Drug: Donepezil HCl |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A 12-Week, Multicenter, Open Label Study To Evaluate The Effectiveness And Safety Of Donepezil Hydrochloride (E2020) In Subjects With Mild To Severe Alzheimer's Disease Residing In An Assisted Living Facility |
Estimated Enrollment: | 100 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Donepezil HCl
One 5 mg tablet per day (for the first 6 weeks) with a full glass of water. For the last 6 weeks, one 10mg tablet per day with a full glass of water.
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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:
Contact: Sunita Hack | sunita_hack@eisai.com |
Study Director: | Anita Murthy | Eisai Inc. |
Responsible Party: | Eisai Inc. ( Eisai Medical Services ) |
Study ID Numbers: | E2020-A001-415 |
Study First Received: | December 6, 2007 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00571064 |
Health Authority: | United States: Institutional Review Board |
Methamphetamine Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil Alzheimer Disease Central Nervous System Diseases |
Amphetamine 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 |