The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior...
Brief Summary
Official Title: “A One-Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)”
To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: March 2007
Intervention(s) in this Clinical Trial
- Drug: Donepezil Hydrochloride
- Subects will receive a starting dose of 5 mg orally. Dose-escalation from 5 mg to 10 mg will occur at the Week 9 Visit.
- Drug: Placebo
- Subjects will receive matching placebo tablets.
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Placebo Comparator: 2
Outcome Measures for this Clinical Trial
Primary Measures
- Assessment of cognitive and global function in subjects with MCI.
Secondary Measures
- Behavioral, global and cognitive outcomes; Neuroimaging
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Memory complaint
- Mini Mental Status Exam (MMSE) score 24-28 inclusive
- General cognition and function performance sufficiently preserved such that a diagnosis of Alzheimer's disease (AD) cannot be made
- Generally healthy and ambulatory
- Sufficiently fluent in English
Exclusion Criteria:
- Diagnosis of probable or possible AD
- Neurological disorders
- History of malignant cancers
- Previously have taken donepezil or other acetylcholinesterase (ChE) inhibitors for more than 1 month or in the past 3 months prior to study entry
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 45 Years
Maximum Age for this Clinical Trial: 90 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Eisai Inc. Industry
Overall Clinical Trial Officials and Contacts
Anita Murthy Study Director Eisai Inc.
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00293176
Study ID Number: E2020-A001-412
ClinicalTrials.gov Identifier: NCT00293176
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00293176
