Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease

NCT00096473

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

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By email

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

- Clinically diagnosed Alzheimer's Disease with MMSE score 1~12

- Have not been treated by any medication for Alzheimer's Disease in past 3 months

- Live in community or Assisted Living Facility

- Healthy or with chronic diseases that are medically controlled or stabilized

- Able to swallow tablets

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


- Any primary neurological or psychiatric diagnosis (including depressive disorder)
other than Alzheimer's Disease


- Dementia caused by organic diseases other than Alzheimer's Disease

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[email protected]

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Alzheimer's Disease, DementiaEfficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease
NCT00096473
  1. Northport, Alabama
  2. Phoenix, Arizona
  3. Sun City, Arizona
  4. Tucson, Arizona
  5. San Francisco, California
  6. Santa Monica, California
  7. Torrance, California
  8. Denver, Colorado
  9. Ft. Lauderdale, Florida
  10. Ft. Myers, Florida
  11. North Miami, Florida
  12. St. Petersburg, Florida
  13. Atlanta, Georgia
  14. Chicago, Illinois
  15. New Orleans, Louisiana
  16. Springfield, Massachusetts
  17. Long Branch, New Jersey
  18. Piscataway, New Jersey
  19. New Hyde Park, New York
  20. Greenville, North Carolina
  21. Raleigh, North Carolina
  22. Centerville, Ohio
  23. Oklahoma City, Oklahoma
  24. Medford, Oregon
  25. Portland, Oregon
  26. Jenkintown, Pennsylvania
  27. Austin, Texas
  28. Houston, Texas
  29. Randwick, New South Wales
  30. Brisbane, Queensland
  31. Woodville South, South Australia
  32. Heidelberg West, Victoria
  33. Nedlands, Western Australia
  34. Toronto, Ontario
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  38. West End, Southampton
  39. Swindon, Wilshire
  40. Bath,
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Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Aricept in the Treatment of Severe Alzheimer's Disease
Official Title  ICMJE A 24 Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Donepezil Hydrochloride (E2020) in Patients With Severe Alzheimer's Disease Followed by a 12 Week Open-Label Extension Period
Brief Summary

Donepezil hydrochloride (Aricept) has been approved to treat symptoms associated with mild to moderate Alzheimer's disease (AD). Aricept has been shown to improve the memory and thinking abilities, activities of daily living and global function in patients. The purpose of the study is to further investigate the effectiveness and safety of donepezil in patients with severe Alzheimer's disease.

Donepezil is thought to work in the brain by increasing the levels of an important brain chemical called acetylcholine. This chemical helps a person's memory to work better.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Alzheimer's Disease
  • Dementia
Intervention  ICMJE Drug: Donepezil hydrochloride
Study Arms  ICMJE Not Provided
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 31, 2011)
229
Original Enrollment  ICMJE
 (submitted: June 23, 2005)
350
Actual Study Completion Date  ICMJE September 2005
Actual Primary Completion Date June 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinically diagnosed Alzheimer's Disease with MMSE score 1~12
  • Have not been treated by any medication for Alzheimer's Disease in past 3 months
  • Live in community or Assisted Living Facility
  • Healthy or with chronic diseases that are medically controlled or stabilized
  • Able to swallow tablets

Exclusion Criteria:

  • Any primary neurological or psychiatric diagnosis (including depressive disorder) other than Alzheimer's Disease
  • Dementia caused by organic diseases other than Alzheimer's Disease
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (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 Australia,   Canada,   France,   Ireland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00096473
Other Study ID Numbers  ICMJE E2020-A001-315
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:Sharon Richardson, Ph.D.Eisai Inc.
Study Director:Honglan Li, Ph.D.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