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

Verified by: Pfizer, July 2009
First Received: September 8, 2005 | Last Updated: July 20, 2009 | Phase: Phase 3 | Start Date: June 2005
Overall Status: Terminated | Estimated Enrollment: 149
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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...

Brief Summary

Official Title: “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 Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: April 2008

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

  • Drug: Donepezil
    • donepezil 5mg/day for 6 weeks and then 5 to 10mg/day for 18 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in Total Score of Standardized Mini-Mental State Examination (sMMSE); Full Analysis Set
    • Time Frame: Baseline, week 12, week 24
      Safety Issue?: No

Secondary Measures

  • Disability Assessment for Dementia Change From Baseline; Activities of Daily Living (ADL) Domain.
    • Time Frame: Baseline, week 12, week 24
      Safety Issue?: No
  • Disability Assessment for Dementia Change From Baseline; Instrumental ADL (IADL) Domain.
    • Time Frame: Baseline, 12 weeks, 24 weeks
      Safety Issue?: No
  • Disability Assessment for Dementia (DAD) Change From Baseline Total Score; Full Analysis Set (FAS)
    • Time Frame: Baseline, week 12, week 24
      Safety Issue?: No
  • Free-hand Drawing Test (CLOX 1) Change From Baseline; Full Analysis Set (FAS)
    • Time Frame: Baseline, 12 weeks, 24 weeks
      Safety Issue?: No
  • Copied Clock Drawing Test (CLOX 2) Change From Baseline; Full Analysis Set (FAS)
    • Time Frame: Baseline, 12 weeks, 24 weeks
      Safety Issue?: No
  • CLOX Differential Score Change From Baseline; Full Analysis Set (FAS)
    • Time Frame: Baseline, 12 weeks, 24 weeks
      Safety Issue?: No
  • Phonectic Fluency Total Score From Baseline; Full Analysis Set (FAS)
    • Time Frame: Baseline, 12 weeks, week 24
      Safety Issue?: No
  • Neuropsychiatric Inventory Questionnaire (NPI-Q) Score Change From Baseline; Full Analysis Set (FAS)
    • Time Frame: Baseline, 12 weeks, 24 weeks
      Safety Issue?: No
  • Neuropsychiatric Inventory Questionnaire Distress (NPI-Q-D) Score Change From Baseline; Full Analysis Set (FAS)
    • Time Frame: Baseline, week 12, week 24
      Safety Issue?: No
  • 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
      Safety Issue?: No
  • Clinical Global Impressions Severity (CGI-S)
    • Time Frame: Baseline
      Safety Issue?: No
  • Clinical Global Impressions Improvement (CGI-I)
    • Time Frame: Week (wk) 24
      Safety Issue?: No
  • Clinical Global Impressions Improvement (CGI-I) Dichotomized Response
    • Time Frame: Baseline, week 24
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00174382

Study ID Number: A2501026

ClinicalTrials.gov Identifier: NCT00174382

Health Authority: Canada: Health Canada

To obtain contact information for a study center near you, click here.

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