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

NCT ID: NCT00174382

Last Updated: 2015-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-04-30

Brief Summary

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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

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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.

Conditions

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Dementia, Vascular Dementia, Mixed

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Donepezil

Intervention Type DRUG

donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks

Interventions

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Donepezil

donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Belvedere, Alberta, Canada

Site Status

Pfizer Investigational Site

Edmonton, Alberta, Canada

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Edmonton, Alberta, Canada

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Abbotsford, British Columbia, Canada

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Coquitlam, British Columbia, Canada

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Victoria, British Columbia, Canada

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Winnipeg, Manitoba, Canada

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Saint John, New Brunswick, Canada

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Amherst, Nova Scotia, Canada

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Halifax, Nova Scotia, Canada

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Pictou, Nova Scotia, Canada

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Burlington, Ontario, Canada

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Corunna, Ontario, Canada

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Fort Erie, Ontario, Canada

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Hawkesbury, Ontario, Canada

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North Bay, Ontario, Canada

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Ottawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Peterborough, Ontario, Canada

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Sarnia, Ontario, Canada

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Toronto, Ontario, Canada

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Beauport, Quebec, Canada

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Cowansville, Quebec, Canada

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L'Ancienne-Lorette, Quebec, Canada

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Montreal, Quebec, Canada

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Rimouski, Quebec, Canada

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Saint-Jean-sur-Richelieu, Quebec, Canada

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Pfizer Investigational Site

Saint-Léonard, Quebec, Canada

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Pfizer Investigational Site

Regina, Saskatchewan, Canada

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Countries

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Canada

Related Links

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Other Identifiers

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A2501026

Identifier Type: -

Identifier Source: org_study_id

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