Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease
Phase 3
Completed
- Conditions
- Dementia Associated With Cerebrovascular Disease
- Registration Number
- NCT00188812
- Lead Sponsor
- University Health Network, Toronto
- Brief Summary
one year extension study following a previous double-blind study to evaluate safety of the drug
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- must have completed previous study E2020-A001-319
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Exclusion Criteria
- absence of a reliable caregiver
- clinically significant medical condition
- recent TIA
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method safety assessments
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Toronto Western Hopital
🇨🇦Toronto, Ontario, Canada