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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00293176
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : April 1, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Memory Loss Drug: Donepezil Hydrochloride Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 821 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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)
Study Start Date : December 2003
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: 1 Drug: 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 Comparator: 2 Drug: Placebo
Subjects will receive matching placebo tablets.

Primary Outcome Measures :
  1. Assessment of cognitive and global function in subjects with MCI.

Secondary Outcome Measures :
  1. Behavioral, global and cognitive outcomes; Neuroimaging

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00293176

  Hide Study Locations
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United States, Alabama
Albaster, Alabama, United States
United States, Arizona
Mesa, Arizona, United States
Peoria, Arizona, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
United States, California
Fresno, California, United States
Garden Grove, California, United States
Irvine, California, United States
San Francisco, California, United States
United States, Colorado
Denver, Colorado, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Florida
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
United States, Georgia
Snellville, Georgia, United States
United States, Illinois
Chicago, Illinois, United States
United States, Indiana
Elkhart, Indiana, United States
United States, Louisiana
New Orleans, Louisiana, United States
United States, Michigan
Farmington Hills, Michigan, United States
Kalamazoo, Michigan, United States
United States, Nevada
Las Vegas, Nevada, United States
United States, New Jersey
Kenilworth, New Jersey, United States
Long Branch, New Jersey, United States
United States, New York
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
United States, North Carolina
No. Charleston, North Carolina, United States
United States, Ohio
Centerville, Ohio, United States
Cleveland, Ohio, United States
Toledo, Ohio, United States
United States, Oregon
Medford, Oregon, United States
Portland, Oregon, United States
United States, Pennsylvania
Greensberg, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
United States, Rhode Island
Providence, Rhode Island, United States
United States, Tennessee
Madison, Tennessee, United States
United States, Texas
Houston, Texas, United States
San Antonio, Texas, United States
Wichita Falls, Texas, United States
United States, Utah
Salt Lake City, Utah, United States
United States, Vermont
Bennington, Vermont, United States
United States, Virginia
Charlottesville, Virginia, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Eisai Inc.
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Study Director: Anita Murthy Eisai Inc.

Layout table for additonal information Identifier: NCT00293176     History of Changes
Obsolete Identifiers: NCT00100022
Other Study ID Numbers: E2020-A001-412
First Posted: February 17, 2006    Key Record Dates
Last Update Posted: April 1, 2011
Last Verified: March 2011

Keywords provided by Eisai Inc.:
Cognitive impairment
Memory Loss

Additional relevant MeSH terms:
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Cognitive Dysfunction
Memory Disorders
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents