Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

University Health Network, Toronto

Overview

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

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Dementia Associated With Cerebrovascular Disease

Interventions

donepezil hclDRUG

Eligibility

Sex: ALLMin age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * must have completed previous study E2020-A001-319 Exclusion Criteria: * absence of a reliable caregiver * clinically significant medical condition * recent TIA

Locations (1)

Toronto Western Hopital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

safety assessments

Data from ClinicalTrials.gov

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