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

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Dementia, Vascular; Dementia, Mixed

Treatments: Drug: Donepezil

Study type: Interventional

Funder types: Industry

Identifiers

NCT00174382

A2501026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 149 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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149 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Donepezil