Clinical Trial: Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a
Brief Summary:
Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. The purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe Alzheimer's disease.
Donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. This chemical helps a person's memory to work better.
Detailed Summary:
Sponsor: Eisai Inc.
Current Primary Outcome: Assessments of global and cognitive function of Severe AD patients
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Assessment of behavior and performance on Activity of Daily Living in severe AD patients
- Assessment of caregiver burden
Original Secondary Outcome: Same as current
Information By: Eisai Inc.
Dates:
Date Received: November 9, 2004
Date Started: January 2001
Date Completion:
Last Updated: March 31, 2011
Last Verified: March 2011
