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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00293176
First Posted: February 17, 2006
Last Update Posted: April 1, 2011
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.
Collaborator:
Pfizer
Information provided by:
Eisai Inc.
February 16, 2006
February 17, 2006
April 1, 2011
December 2003
March 2007   (Final data collection date for primary outcome measure)
Assessment of cognitive and global function in subjects with MCI.
Same as current
Complete list of historical versions of study NCT00293176 on ClinicalTrials.gov Archive Site
Behavioral, global and cognitive outcomes; Neuroimaging
Same as current
Not Provided
Not Provided
 
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Memory Loss
  • 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.
  • Drug: Placebo
    Subjects will receive matching placebo tablets.
  • Experimental: 1
    Intervention: Drug: Donepezil Hydrochloride
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
821
March 2007
March 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
45 Years to 90 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00293176
E2020-A001-412
Not Provided
Not Provided
Not Provided
Not Provided
Eisai Inc.
Pfizer
Study Director: Anita Murthy Eisai Inc.
Eisai Inc.
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP