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

Purpose

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

Condition	Intervention	Phase
Memory Loss	Drug: Donepezil Hydrochloride Drug: Placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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)

Resource links provided by NLM:

MedlinePlus related topics: Memory Mild Cognitive Impairment

Drug Information available for: Donepezil hydrochloride Donepezil

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Assessment of cognitive and global function in subjects with MCI.

Secondary Outcome Measures:

Behavioral, global and cognitive outcomes; Neuroimaging

Enrollment:	821
Study Start Date:	December 2003
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	45 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293176

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Locations

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.

Pfizer

Investigators

Study Director:

Anita Murthy

Eisai Inc.

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00293176 History of Changes
Obsolete Identifiers:	NCT00100022
Other Study ID Numbers:	E2020-A001-412
Study First Received:	February 16, 2006
Last Updated:	March 31, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eisai Inc.:

Cognitive impairment
Memory Loss

Additional relevant MeSH terms:

Amnesia
Memory Disorders
Cognition Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil

Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013