NCT00293176CompletedPhase 4
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Eisai Inc.
- Enrollment
- 821
- Primary Endpoint
- Assessment of cognitive and global function in subjects with MCI.
Study Overview
Brief Summary
To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 45 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
Intervention: Donepezil Hydrochloride (Drug)
2
Placebo Comparator
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Assessment of cognitive and global function in subjects with MCI.
Secondary Outcomes
- Behavioral, global and cognitive outcomes; Neuroimaging
Investigators
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