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)

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

Study Overview

• Status: Completed
• Conditions: Memory Loss
• Intervention / Treatment: Drug: Donepezil Hydrochloride; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 821
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Assessment of cognitive and global function in subjects with MCI.

Secondary Outcome Measures

Outcome Measure
Behavioral, global and cognitive outcomes; Neuroimaging

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Collaborators: Pfizer
• Investigators: Study Director: Anita Murthy, Eisai Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2003
• Primary Completion (Actual): March 1, 2007
• Study Completion (Actual): March 1, 2007

Study Registration Dates

• First Submitted: February 16, 2006
• First Submitted That Met QC Criteria: February 16, 2006
• First Posted (Estimate): February 17, 2006

Study Record Updates

• Last Update Posted (Estimate): April 1, 2011
• Last Update Submitted That Met QC Criteria: March 31, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Cognitive impairment; Memory Loss
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Memory Disorders; Amnesia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: E2020-A001-412