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: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: April 2008

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

Primary Measures

• To evaluate whether donepezil will increase general cognition as measured by the SMMSE in subjects with vascular dementia and mixed dementia (Alzheimer's disease/Vascular Dementia).
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• To evaluate the safety of donepezil , as well as its effect on executive functioning, behavior, and ADLs in subjects with vascular and mixed dementia (Alzheimer's disease/Vascular dementia).
  • Time Frame: 6 months
    Safety Issue?: Yes

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

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Information obtained from ClinicalTrials.gov on December 03, 2008

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

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