Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia
The purpose of this study is to examine the efficacy and safety of cholinesterase inhibitor (donepezil hydrochloride) Aricept in patients with vascular dementia (VaD).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Study on the Efficacy and Safety of Donepezil Hydrochloride (Aricept) in Vascular Dementia|
- Clinician's Interview Based Impression of Change-Plus Caregiver Input (CIBIC-Plus). [ Time Frame: 6,12,18, 24 weeks. ] [ Designated as safety issue: No ]
- Vascular Dementia Assessment Scale cognitive subscale (VaDAS-cog). [ Time Frame: 6,12,18, 24 weeks. ] [ Designated as safety issue: No ]
|Study Start Date:||September 2005|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
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.
Other Name: Aricept
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00165763
|Quezon, Manila, Philippines|
|Subic Bay Medical Center|
|Olongapo, Zambales, Philippines|
|Study Chair:||Jacqueline Dominguez||Memory Center, St. Luke's Medical Center|