The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
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)
1 other identifier
interventional
821
1 country
54
Brief Summary
To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2003
Typical duration for phase_4
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 16, 2006
CompletedFirst Posted
Study publicly available on registry
February 17, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedApril 1, 2011
March 1, 2011
3.2 years
February 16, 2006
March 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of cognitive and global function in subjects with MCI.
Secondary Outcomes (1)
Behavioral, global and cognitive outcomes; Neuroimaging
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
- Pfizercollaborator
Study Sites (54)
Unknown Facility
Albaster, Alabama, United States
Unknown Facility
Mesa, Arizona, United States
Unknown Facility
Peoria, Arizona, United States
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Sun City, Arizona, United States
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Tucson, Arizona, United States
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Fresno, California, United States
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Garden Grove, California, United States
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Irvine, California, United States
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San Francisco, California, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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Boynton Beach, Florida, United States
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Fort Meyers, Florida, United States
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Hollywood, Florida, United States
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Jacksonville, Florida, United States
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Melbourne, Florida, United States
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North Miami, Florida, United States
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Ocala, Florida, United States
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Sarasota, Florida, United States
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St. Petersburg, Florida, United States
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Tampa, Florida, United States
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Venice, Florida, United States
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West Palm Beach, Florida, United States
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Snellville, Georgia, United States
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Chicago, Illinois, United States
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Elkhart, Indiana, United States
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New Orleans, Louisiana, United States
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Farmington Hills, Michigan, United States
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Kalamazoo, Michigan, United States
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Las Vegas, Nevada, United States
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Kenilworth, New Jersey, United States
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Long Branch, New Jersey, United States
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Albany, New York, United States
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Lexington, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Staten Island, New York, United States
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No. Charleston, North Carolina, United States
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Centerville, Ohio, United States
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Cleveland, Ohio, United States
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Toledo, Ohio, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Greensberg, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Madison, Tennessee, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Wichita Falls, Texas, United States
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Salt Lake City, Utah, United States
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Bennington, Vermont, United States
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Charlottesville, Virginia, United States
Unknown Facility
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Anita Murthy
Eisai Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 16, 2006
First Posted
February 17, 2006
Study Start
December 1, 2003
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
April 1, 2011
Record last verified: 2011-03