The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
NCT ID: NCT00293176
Last Updated: 2011-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
821 participants
INTERVENTIONAL
2003-12-31
2007-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
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.
2
Placebo
Subjects will receive matching placebo tablets.
Interventions
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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.
Placebo
Subjects will receive matching placebo tablets.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
90 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Eisai Inc.
INDUSTRY
Principal Investigators
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Anita Murthy
Role: STUDY_DIRECTOR
Eisai Inc.
Locations
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Albaster, Alabama, United States
Mesa, Arizona, United States
Peoria, Arizona, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
Fresno, California, United States
Garden Grove, California, United States
Irvine, California, United States
San Francisco, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Boynton Beach, Florida, United States
Fort Meyers, Florida, United States
Hollywood, Florida, United States
Jacksonville, Florida, United States
Melbourne, Florida, United States
North Miami, Florida, United States
Ocala, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Venice, Florida, United States
West Palm Beach, Florida, United States
Snellville, Georgia, United States
Chicago, Illinois, United States
Elkhart, Indiana, United States
New Orleans, Louisiana, United States
Farmington Hills, Michigan, United States
Kalamazoo, Michigan, United States
Las Vegas, Nevada, United States
Kenilworth, New Jersey, United States
Long Branch, New Jersey, United States
Albany, New York, United States
Lexington, New York, United States
New York, New York, United States
Rochester, New York, United States
Staten Island, New York, United States
No. Charleston, North Carolina, United States
Centerville, Ohio, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
Medford, Oregon, United States
Portland, Oregon, United States
Greensberg, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Providence, Rhode Island, United States
Madison, Tennessee, United States
Houston, Texas, United States
San Antonio, Texas, United States
Wichita Falls, Texas, United States
Salt Lake City, Utah, United States
Bennington, Vermont, United States
Charlottesville, Virginia, United States
Seattle, Washington, United States
Countries
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Other Identifiers
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E2020-A001-412
Identifier Type: -
Identifier Source: org_study_id
NCT00100022
Identifier Type: -
Identifier Source: nct_alias
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