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

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NCT00174382

Last updated on April 2, 2020
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Study Location
Pfizer Investigational Site
Belvedere, Alberta, T5C 0A3 Canada
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Contact
1-800-718-1021
[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.

NCT00174382
Pfizer
Terminated
Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia

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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 Center Pfizer
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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