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

Primary Purpose

Memory Loss

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Donepezil Hydrochloride
Placebo
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Memory Loss focused on measuring Cognitive impairment, Memory Loss

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Assessment of cognitive and global function in subjects with MCI.

Secondary Outcome Measures

Behavioral, global and cognitive outcomes; Neuroimaging

Full Information

First Posted
February 16, 2006
Last Updated
March 31, 2011
Sponsor
Eisai Inc.
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00293176
Brief Title
The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eisai Inc.
Collaborators
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Loss
Keywords
Cognitive impairment, Memory Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
821 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Donepezil Hydrochloride
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Subjects will receive matching placebo tablets.
Primary Outcome Measure Information:
Title
Assessment of cognitive and global function in subjects with MCI.
Secondary Outcome Measure Information:
Title
Behavioral, global and cognitive outcomes; Neuroimaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Murthy
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
City
Albaster
State/Province
Alabama
Country
United States
City
Mesa
State/Province
Arizona
Country
United States
City
Peoria
State/Province
Arizona
Country
United States
City
Sun City
State/Province
Arizona
Country
United States
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Tucson
State/Province
Arizona
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United States
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Fresno
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California
Country
United States
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Garden Grove
State/Province
California
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United States
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Irvine
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California
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United States
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San Francisco
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California
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United States
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Denver
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Colorado
Country
United States
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New Haven
State/Province
Connecticut
Country
United States
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Boynton Beach
State/Province
Florida
Country
United States
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Fort Meyers
State/Province
Florida
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United States
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Hollywood
State/Province
Florida
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United States
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Jacksonville
State/Province
Florida
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United States
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Melbourne
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Florida
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United States
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North Miami
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Florida
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United States
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Ocala
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Florida
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United States
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Sarasota
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Florida
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United States
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St. Petersburg
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Florida
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United States
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Tampa
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Florida
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United States
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Venice
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Florida
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United States
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West Palm Beach
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Florida
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United States
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Snellville
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Georgia
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United States
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Chicago
State/Province
Illinois
Country
United States
City
Elkhart
State/Province
Indiana
Country
United States
City
New Orleans
State/Province
Louisiana
Country
United States
City
Farmington Hills
State/Province
Michigan
Country
United States
City
Kalamazoo
State/Province
Michigan
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United States
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Las Vegas
State/Province
Nevada
Country
United States
City
Kenilworth
State/Province
New Jersey
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United States
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Long Branch
State/Province
New Jersey
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United States
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Albany
State/Province
New York
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United States
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Lexington
State/Province
New York
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United States
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New York
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New York
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United States
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Rochester
State/Province
New York
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United States
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Staten Island
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New York
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United States
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No. Charleston
State/Province
North Carolina
Country
United States
City
Centerville
State/Province
Ohio
Country
United States
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Cleveland
State/Province
Ohio
Country
United States
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Toledo
State/Province
Ohio
Country
United States
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Medford
State/Province
Oregon
Country
United States
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Portland
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Oregon
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United States
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Greensberg
State/Province
Pennsylvania
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United States
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Pittsburgh
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Pennsylvania
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United States
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Providence
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Rhode Island
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United States
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Madison
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Tennessee
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United States
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Houston
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Texas
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United States
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San Antonio
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Texas
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United States
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Wichita Falls
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
Bennington
State/Province
Vermont
Country
United States
City
Charlottesville
State/Province
Virginia
Country
United States
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

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

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