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Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00188812
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : January 12, 2009
Eisai Inc.
Information provided by:
University Health Network, Toronto

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

Condition or disease Intervention/treatment Phase
Dementia Associated With Cerebrovascular Disease Drug: donepezil hcl Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2004
Estimated Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia
U.S. FDA Resources

Primary Outcome Measures :
  1. safety assessments

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • must have completed previous study E2020-A001-319

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188812

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

ClinicalTrials.gov Identifier: NCT00188812     History of Changes
Other Study ID Numbers: 03-0725-AE
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: January 12, 2009
Last Verified: September 2005

Keywords provided by University Health Network, Toronto:

Additional relevant MeSH terms:
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Vascular Diseases
Cardiovascular Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents