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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2007

Intervention(s) in this Clinical Trial

• Drug: Donepezil Hydrochloride

Primary Measures

• Assessment of cognitive and global function in subjects with MCI.

Secondary Measures

• Behavioral, global and cognitive outcomes; Neuroimaging

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

Lead Sponsor: Eisai Inc.

Overall Clinical Trial Officials and Contacts

Anita Murthy Study Director Eisai Inc.  

Information obtained from ClinicalTrials.gov on November 19, 2008

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