NCT00165763

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Vascular Dementia

Interventions

Type	Name	Description
DRUG	donepezil hydrochloride (Aricept)	5 mg donepezil HCl given once a day and increased to 10 mg per day if side effects, when present, are tolerated.

Timeline

• Start date: 2005-09-01
• Primary completion: 2009-09-01
• First posted: 2005-09-14
• Last updated: 2012-05-04

Locations

2 sites across 1 country: Philippines