Clinical Trial: Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: An Open Label Study on the Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia

Brief Summary: The purpose of this study is to examine the efficacy and safety of cholinesterase inhibitor (donepezil hydrochloride) Aricept in patients with vascular dementia (VaD).

Detailed Summary: Vascular dementia is a significant cause of intellectual and functional impairment in young patients consequent to cerebrovascular disease. Post-mortem studies show that VaD patients have a cholinergic deficiency like in Alzheimer's disease (AD). Cholinesterase inhibitors are now standard treatment for mild to moderate AD. This study aims to determine if donepezil, a cholinesterase inhibitor, would benefit patients with VaD by decreasing their scores in the VaDAS-cog and improvement in their CIBIC rating over a period of 24-weeks treatment. Adverse events will also be monitored.
Sponsor: Eisai Inc.

Current Primary Outcome: Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus). [ Time Frame: 6,12,18, 24 weeks. ]

Original Primary Outcome:

Current Secondary Outcome: Vascular Dementia Assessment Scale cognitive subscale (VaDAS-cog). [ Time Frame: 6,12,18, 24 weeks. ]

Original Secondary Outcome:

Information By: Eisai Inc.

Dates:
Date Received: September 12, 2005
Date Started: September 2005
Date Completion:
Last Updated: May 2, 2012
Last Verified: September 2009