Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

Dementia Associated With Cerebrovascular Disease Clinical Trial

Official title: Open-Label, Multicentre, One Year Extension of the Evaluation of the Safety of Donepezil Hcl in Patients With Dementia Associated With Cerebrovascular Disease

Status Completed

Clinical Trial Summary

one year extension study following a previous double-blind study to evaluate safety of the drug

Clinical Trial Description

A one year extension study for patients who completed E2020-A001-319. Patients will receive 5my donepezil daily for the first 8 weeks and will be assessed by the incidence of advere events, changes in physical exams, ECG and clinical lab determinations. The results will be assessed 6 timues during the year. After 8 week, the investigator may increase the dose to 10mg/day if the patient if the patients show satisfactory tolerability. Six psychometric scales will also be evaluatd. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Disorders
• Dementia
• Dementia Associated With Cerebrovascular Disease

• NCT number: NCT00188812
• Study type: Interventional
• Source: University Health Network, Toronto
• Status: Completed
• Phase: Phase 3
• Start date: May 2004
• Completion date: August 2005