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

NCT00293176

Last updated date
Study Location
Albaster, Alabama, , United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Memory Loss
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Memory LossThe Evaluation of the Efficacy and Safety of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment (MCI)
NCT00293176
  1. Albaster, Alabama
  2. Mesa, Arizona
  3. Peoria, Arizona
  4. Sun City, Arizona
  5. Tucson, Arizona
  6. Fresno, California
  7. Garden Grove, California
  8. Irvine, California
  9. San Francisco, California
  10. Denver, Colorado
  11. New Haven, Connecticut
  12. Boynton Beach, Florida
  13. Fort Meyers, Florida
  14. Hollywood, Florida
  15. Jacksonville, Florida
  16. Melbourne, Florida
  17. North Miami, Florida
  18. Ocala, Florida
  19. Sarasota, Florida
  20. St. Petersburg, Florida
  21. Tampa, Florida
  22. Venice, Florida
  23. West Palm Beach, Florida
  24. Snellville, Georgia
  25. Chicago, Illinois
  26. Elkhart, Indiana
  27. New Orleans, Louisiana
  28. Farmington Hills, Michigan
  29. Kalamazoo, Michigan
  30. Las Vegas, Nevada
  31. Kenilworth, New Jersey
  32. Long Branch, New Jersey
  33. Albany, New York
  34. Lexington, New York
  35. New York, New York
  36. Rochester, New York
  37. Staten Island, New York
  38. No. Charleston, North Carolina
  39. Centerville, Ohio
  40. Cleveland, Ohio
  41. Toledo, Ohio
  42. Medford, Oregon
  43. Portland, Oregon
  44. Greensberg, Pennsylvania
  45. Pittsburgh, Pennsylvania
  46. Providence, Rhode Island
  47. Madison, Tennessee
  48. Houston, Texas
  49. San Antonio, Texas
  50. Wichita Falls, Texas
  51. Salt Lake City, Utah
  52. Bennington, Vermont
  53. Charlottesville, Virginia
  54. Seattle, Washington
ALL GENDERS
45 Years+
years
MULTIPLE SITES
Advanced Information
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  ICMJE 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  ICMJE
  • 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  ICMJE 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  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 45 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Anita MurthyEisai 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