Vaspect Study - An Open-Label Trial Of Donepezil in Vascular and Mixed Dementia
NCT00174382
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
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
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
- Belvedere, Alberta
- Edmonton, Alberta
- Edmonton, Alberta
- Abbotsford, British Columbia
- Coquitlam, British Columbia
- Victoria, British Columbia
- Winnipeg, Manitoba
- Saint John, New Brunswick
- Amherst, Nova Scotia
- Halifax, Nova Scotia
- Pictou, Nova Scotia
- Burlington, Ontario
- Corunna, Ontario
- Fort Erie, Ontario
- Hawkesbury, Ontario
- North Bay, Ontario
- Ottawa, Ontario
- Ottawa, Ontario
- Ottawa, Ontario
- Peterborough, Ontario
- Sarnia, Ontario
- Toronto, Ontario
- Beauport, Quebec
- Cowansville, Quebec
- L'Ancienne-Lorette, Quebec
- Montréal, Quebec
- Rimouski, Quebec
- St-Jean-sur-Richelieu, Quebec
- St. Leonard, Quebec
- 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 |
| |||
| 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 | 149 | |||
| Original Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| 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 |
| |||
| 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 | ||||