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

March 4, 2015 updated by: Pfizer

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

149

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Belvedere, Alberta, Canada, T5C 0A3
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T5A 4L8
        • Pfizer Investigational Site
      • Edmonton, Alberta, Canada, T6A 0A5
        • Pfizer Investigational Site
    • British Columbia
      • Abbotsford, British Columbia, Canada, V2S 3P8
        • Pfizer Investigational Site
      • Coquitlam, British Columbia, Canada, V3K 3P4
        • Pfizer Investigational Site
      • Victoria, British Columbia, Canada, V8T 5G1
        • Pfizer Investigational Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 0R8
        • Pfizer Investigational Site
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 3L6
        • Pfizer Investigational Site
    • Nova Scotia
      • Amherst, Nova Scotia, Canada, B4H 4R7
        • Pfizer Investigational Site
      • Halifax, Nova Scotia, Canada, B3H 2E1
        • Pfizer Investigational Site
      • Pictou, Nova Scotia, Canada, B0K 1H0
        • Pfizer Investigational Site
    • Ontario
      • Burlington, Ontario, Canada, L7M 4Y1
        • Pfizer Investigational Site
      • Corunna, Ontario, Canada, N0N 1G0
        • Pfizer Investigational Site
      • Fort Erie, Ontario, Canada, L2A 1Z3
        • Pfizer Investigational Site
      • Hawkesbury, Ontario, Canada, K6A 1A1
        • Pfizer Investigational Site
      • North Bay, Ontario, Canada, P1B 2H3
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K1N 5C8
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K2C 3R2
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada, K2G 3Y5
        • Pfizer Investigational Site
      • Peterborough, Ontario, Canada, K9H 2P4
        • Pfizer Investigational Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M3B 2W7
        • Pfizer Investigational Site
    • Quebec
      • Beauport, Quebec, Canada, G1J 2G3
        • Pfizer Investigational Site
      • Cowansville, Quebec, Canada, J2K 2X9
        • Pfizer Investigational Site
      • L'Ancienne-Lorette, Quebec, Canada, G2E 2X1
        • Pfizer Investigational Site
      • Montréal, Quebec, Canada, H1T 2M4
        • Pfizer Investigational Site
      • Rimouski, Quebec, Canada, G5L 9A8
        • Pfizer Investigational Site
      • St-Jean-sur-Richelieu, Quebec, Canada, J2W 2A3
        • Pfizer Investigational Site
      • St. Leonard, Quebec, Canada, H1S 3A9
        • Pfizer Investigational Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4P 3X1
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Donepezil
donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set
Time Frame: Baseline, week 12, week 24
Change from baseline in sMMSE total score. Change: mean total score at observation minus mean total score at baseline. Total score is derived by adding all subscores and ranges from 0 to 30; a higher score indicates a better cognitive state.
Baseline, week 12, week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.
Time Frame: Baseline, week 12, week 24
The ADL domain includes 17 yes/no questions on four items (hygiene, dressing, continence, eating). Score equals number of questions answered yes multiplied by 100 divided by number of questions answered. Change: Mean ADL score at observation minus mean ADL score at baseline.
Baseline, week 12, week 24
Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.
Time Frame: Baseline, 12 weeks, 24 weeks
IADL domain consists of 23 yes-no questions on 6 items (meal preparation, telephoning, going out, finance & correspondence, medications, leisure & housework. Change: Mean IADL score at observation minus mean IADL score at baseline. Total IADL score = number of questions answered yes multiplied by 100 divided by total number of questions answered
Baseline, 12 weeks, 24 weeks
Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)
Time Frame: Baseline, week 12, week 24
DAD total score equals total number of questions answered yes multiplied by 100 divided by total number of questions answered.
Baseline, week 12, week 24
Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)
Time Frame: Baseline, 12 weeks, 24 weeks
The ability to draw a clock free-hand. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 1 score at observation minus mean CLOX score at baseline.
Baseline, 12 weeks, 24 weeks
Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)
Time Frame: Baseline, 12 weeks, 24 weeks
The ability to copy a drawing of a clock. Scored on a scale from 1 to 15; lower scores indicate higher impairment. Change: Mean CLOX 2 score at observation minus mean CLOX 2 score at baseline.
Baseline, 12 weeks, 24 weeks
CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)
Time Frame: Baseline, 12 weeks, 24 weeks
CLOX differential score equals the difference between the score for CLOX 2 and the score for CLOX 1, values range from 15 to 0, with 0 indicating perfect executive function, and a worsening with the increasing score.
Baseline, 12 weeks, 24 weeks
Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)
Time Frame: Baseline, 12 weeks, week 24
The number of words a particpant can generate in 1 minute.
Baseline, 12 weeks, week 24
Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)
Time Frame: Baseline, 12 weeks, 24 weeks
NPI-Q measures severity of behavioural manifestations of dementia & the level of distress each symptom gives the main caregiver, 1 (mild), 3 (severe), 0 if symptom absent, NPI-Q also measures the caregiver distress associated with each symptom,0(no distress)to 5(very severe), total score equals sum of individual item scores & ranges from 0 to 36
Baseline, 12 weeks, 24 weeks
Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)
Time Frame: Baseline, week 12, week 24
The total NPI-Q-D score is equal to the sum of all indiviudal symptom distress scale scores with a range of 0 to 60
Baseline, week 12, week 24
Clinical Global Impressions Severity Score (CGI-S) Clinical Global Impressions Severity Score Improvement(CGI-I)Change From Baseline, Full Analysis Set (FAS)
Time Frame: Baseline, week 24
Scale measures subject's clinical condition at baseline for severity (CGI-S) & for improvement from baseline (CGI-I). At baseline subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill). At follow up subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) & 4 indicates no change from baseline
Baseline, week 24
Clinical Global Impressions Severity (CGI-S)
Time Frame: Baseline
Scale measures subject's clinical condition at baseline for severity (CGI-S) subject rated on numerical scale, 1 (not at all ill) to 7 (most extremely ill).
Baseline
Clinical Global Impressions Improvement (CGI-I)
Time Frame: Week (wk) 24
Scale measures subject's clinical condition for improvement from baseline (CGI-I)subject rated on 7 point Likert scale from 1(very much improved) to 7(very much worse) & 4 indicates no change from baseline
Week (wk) 24
Clinical Global Impressions Improvement (CGI-I) Dichotomized Response
Time Frame: Baseline, week 24
Scale measures subject's (CGI-I) rated on categorial 7 point Likert scale 1 (very much improved) to 7 (very much worse) with 4 indicating no change from baseline. A dichotomized variable was created: responder = CGI-I score of 4 or less; non-responder = CGI-I score of 5 or more
Baseline, week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

March 24, 2015

Last Update Submitted That Met QC Criteria

March 4, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2501026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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