Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

University Health Network, Toronto

Status and phase: Completed; Phase 3

Conditions: Dementia Associated With Cerebrovascular Disease

Treatments: Drug: donepezil hcl

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00188812

E2020-A001-320

03-0725-AE

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• must have completed previous study E2020-A001-319

Exclusion criteria

• absence of a reliable caregiver
• clinically significant medical condition
• recent TIA

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)