The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)

Phase 4

Completed

• Conditions: Memory Loss
• Interventions: Drug: Donepezil Hydrochloride; Drug: Placebo

• Registration Number: NCT00293176
• Lead Sponsor: Eisai Inc.

Brief Summary

To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2006-02-16
• Study First Submitted QC: 2006-02-16
• Study First Posted: 2006-02-17
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-31
• Last Update Posted: 2011-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 821

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Donepezil Hydrochloride	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
Assessment of cognitive and global function in subjects with MCI.

Secondary Outcome Measures

Name	Time	Method
Behavioral, global and cognitive outcomes; Neuroimaging