Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

This study has been completed.
Sponsor:
Collaborator:
Eisai Inc.
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00188812
First received: September 12, 2005
Last updated: January 9, 2009
Last verified: September 2005
  Purpose

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


Condition Intervention Phase
Dementia Associated With Cerebrovascular Disease
Drug: donepezil hcl
Phase 3

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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • safety assessments

Study Start Date: May 2004
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • must have completed previous study E2020-A001-319

Exclusion Criteria:

  • absence of a reliable caregiver
  • clinically significant medical condition
  • recent TIA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188812

Locations
Canada, Ontario
Toronto Western Hopital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Eisai Inc.
Investigators
Principal Investigator: Karl Farcnik, MD FRCP(C) University Health Network, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00188812     History of Changes
Other Study ID Numbers: 03-0725-AE, E2020-A001-320
Study First Received: September 12, 2005
Last Updated: January 9, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University Health Network, Toronto:
dementia
stroke

Additional relevant MeSH terms:
Dementia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Vascular Diseases
Cardiovascular Diseases
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014