Skip to main content
OpenTrials
Completed

NCT Number: NCT00188812

Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dementia Associated With Cerebrovascular Disease Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Stroke Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Toronto Western Hopital

Toronto, Ontario, M5T 2S8, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • must have completed previous study E2020-A001-319

Exclusion criteria

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

Treatment and study plan

Donepezil HCl

Drug

Primary outcomes

  1. safety assessments

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Eisai Inc.

Registry information

Official study title

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

Important dates

Study start
2004
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Jan 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.