Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

NCT00174382

Last updated date
Study Location
Pfizer Investigational Site
Belvedere, Alberta, T5C 0A3, Canada
Contact
1-800-718-1021

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Vascular Dementia, Mixed 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

- Subjects must meet DSM-IV-TR criteria for the clinical diagnosis of Vascular Dementia or the clinical diagnosis of dementia due to multiple etiologies.

- Subjects must have a reliable caregiver or family member who agrees to accompany the subject to all scheduled visits, provide information about the subject as required.

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


- Subjects with any current primary psychiatric diagnosis other than dementia of the
Alzheimer's type or Vascular Dementia.

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Vascular Dementia, Mixed DementiaVaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
NCT00174382
  1. Belvedere, Alberta
  2. Edmonton, Alberta
  3. Edmonton, Alberta
  4. Abbotsford, British Columbia
  5. Coquitlam, British Columbia
  6. Victoria, British Columbia
  7. Winnipeg, Manitoba
  8. Saint John, New Brunswick
  9. Amherst, Nova Scotia
  10. Halifax, Nova Scotia
  11. Pictou, Nova Scotia
  12. Burlington, Ontario
  13. Corunna, Ontario
  14. Fort Erie, Ontario
  15. Hawkesbury, Ontario
  16. North Bay, Ontario
  17. Ottawa, Ontario
  18. Ottawa, Ontario
  19. Ottawa, Ontario
  20. Peterborough, Ontario
  21. Sarnia, Ontario
  22. Toronto, Ontario
  23. Beauport, Quebec
  24. Cowansville, Quebec
  25. L'Ancienne-Lorette, Quebec
  26. Montréal, Quebec
  27. Rimouski, Quebec
  28. St-Jean-sur-Richelieu, Quebec
  29. St. Leonard, Quebec
  30. Regina, Saskatchewan
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
Official Title  ICMJE An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
Brief Summary To document effectiveness, safety, and tolerability of donepezil in patients with mixed AD/VaD, and to further document the effectiveness, safety, and tolerability of donepezil in patients with VaD. The effects of donepezil on executive functioning, behavior, general cognition, ADLs and global functioning will be assessed.
Detailed Description The trial was terminated on October 15, 2007 due to difficulties in recruiting the subjects. There were no safety or efficacy concerns regarding the study medication in the decision to terminate the trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Dementia, Vascular
  • Dementia, Mixed
Intervention  ICMJE Drug: Donepezil
donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Donepezil
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 Terminated
Actual Enrollment  ICMJE
 (submitted: September 24, 2008)
149
Original Enrollment  ICMJE
 (submitted: September 9, 2005)
260
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects must meet DSM-IV-TR criteria for the clinical diagnosis of Vascular Dementia or the clinical diagnosis of dementia due to multiple etiologies.
  • Subjects must have a reliable caregiver or family member who agrees to accompany the subject to all scheduled visits, provide information about the subject as required.

Exclusion Criteria:

  • Subjects with any current primary psychiatric diagnosis other than dementia of the Alzheimer's type or Vascular Dementia.
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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174382
Other Study ID Numbers  ICMJE A2501026
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date March 2015

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