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Trial record 1 of 1 for:    NCT00293176
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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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ClinicalTrials.gov Identifier: NCT00293176
Recruitment Status : Completed
First Posted : February 17, 2006
Last Update Posted : April 1, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE February 16, 2006
First Posted Date  ICMJE February 17, 2006
Last Update Posted Date April 1, 2011
Study Start Date  ICMJE December 2003
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 16, 2006)
Assessment of cognitive and global function in subjects with MCI.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00293176 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2006)
Behavioral, global and cognitive outcomes; Neuroimaging
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE The Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
Official Title  ICMJE 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)
Brief Summary To investigate the efficacy and safety of donepezil in individuals with mild cognitive impairment on measures of cognition, global function and behavior.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Memory Loss
Intervention  ICMJE
  • 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.
Study Arms
  • Experimental: 1
    Intervention: Drug: Donepezil Hydrochloride
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2007)
821
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date March 2007
Actual Primary Completion Date March 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00293176
Other Study ID Numbers  ICMJE E2020-A001-412
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Anita Murthy Eisai Inc.
PRS Account Eisai Inc.
Verification Date March 2011

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