Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease

This study has been completed.

First Received: September 12, 2005 Last Updated: January 9, 2009 History of Changes

Sponsors and Collaborators:	University Health Network, Toronto Eisai Medical Research Inc.
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188812

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 III

MedlinePlus related topics: Dementia

Drug Information available for: E 2020 Donepezil

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study
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

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

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 Medical Research Inc.

Investigators

Principal Investigator:

Karl Farcnik, MD FRCP(C)

University Health Network, Toronto

More Information

No publications provided

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

Keywords provided by University Health Network, Toronto:

dementia
stroke

Study placed in the following topic categories:

Nootropic Agents
Neurotransmitter Agents
Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Cholinergic Agents
Brain Diseases

Cerebrovascular Disorders
Cognition Disorders
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Donepezil
Dementia
Delirium

Additional relevant MeSH terms:

Nootropic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents
Brain Diseases

Cerebrovascular Disorders
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Donepezil
Cardiovascular Diseases
Dementia
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009