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Donepezil Hydrochloride (E2020) in Dementia Associated With Cerebrovascular Disease

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00165737
First received: September 12, 2005
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

Twenty-four week, prospective, randomized, double-blind, placebo-controlled, parallel-group study.


Condition Intervention Phase
Dementia, Vascular
Drug: Donepezil Hydrochloride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A 24-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy, Safety and Tolerability of Donepezil Hydrochloride (E2020) in Patients With Dementia Associated With Cerebrovascular Disease

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Safety: physical examinations, ECG and clinical laboratory tests. Efficacy: Vascular-Alzheimer's Disease Assessment Scale-Cognitive subscale (V-ADAS-cog) and the Clinician's Interview-Based Impression of Change-Plus Version (CIBIC-Plus). [ Time Frame: Parameters will be measured prior to, during and at the end of the study. ]

Enrollment: 974
Study Start Date: March 2003
Study Completion Date: June 2006
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   41 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

1. Age range: Adult patients (>40 years old) 2 Possible or Probable Dementia associated with cerebrovascular disease as defined by NINDS-AIREN Criteria with dementia of greater than 3 months duration.

3. Radiological evidence of cerebrovascular disease. 4. Sex distribution: Both men and women. Women of child-bearing potential (<1 year post menopausal) must be willing to practice effective contraception and have a negative serum B-HCG at Screening. Pregnant and/or lactating females are excluded.

5. Race and Health: Any generally healthy, ambulatory or ambulatory aided (i.e., walker, cane or wheelchair) outpatient. Vision and hearing (glasses, contact lens, and hearing aid permissible), speech, motor function and comprehension must be sufficient for compliance with all testing procedures.

6. Patients with risk factors of hypertension and cardiac disease may be enrolled in the study, provided that hypertension is medication controlled (supine diastolic BP < 95 mm Hg) and cardiac disease (e.g. angina pectoris, congestive heart failure, right bundle branch block, or arrhythmias) is stable on appropriate medication for 3 months prior to Screening. Peripheral vascular disease must have been stable for 3 months prior to Screening. No elective surgical procedures should be planned during the course of the study (e.g., vascular bypass procedures or coronary artery bypass surgery).

7. Patients with risk factors of diabetes mellitus may be enrolled in the study, provided that the patient's disease is stable and that there have been no recent (within 3 months) admissions for diabetic ketoacidosis, hyperosmolar coma, or hypoglycemia. Patients with non-insulin-dependent diabetes may enroll in the study if controlled on diet or oral medications. All diabetic patients must have a HbA1c concentration of <=10% and a plasma glucose concentration of <= 250 mg/dL.

8. Patients with risk factors of stroke may be enrolled in the study, provided that the disease process has been stable or controlled on medication for greater than 3 months prior to Screening. Patients receiving anticoagulation with warfarin are eligible for inclusion in the study if the International Normalized Ratio (INR) for prothrombin time is within the therapeutic range for prophylaxis (1.4-3.0) and the dose of warfarin is stable.

-- Patients with prosthetic heart valves, who require full anticoagulation, should have a stable (>= 3 months) INR in the range of 2.5-3.5.

9. Patients who have taken a previously approved cholinesterase inhibitor (e.g., Aricept., Exelon., Reminyl., Cognex.) or memantine (Ebixa, Akinatol) are allowed provided that the medication was discontinued at least six (6) weeks prior to Screening.

10. Patients with thyroid disease may be included in the study, provided they are euthyroid on treatment.

11. Patient and study partner are willing to participate and have provided written Informed Consent prior to being exposed to any study-related procedures.

  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: NCT00165737

Locations
United States, Arkansas
Central Arkansas Research (CARE)
Hot Springs, Arkansas, United States, 71913
United States, Florida
Comprehensive Neuroscience
St. Petersburg, Florida, United States, 33702
United States, Illinois
St. Francis Medical Center
Peoria, Illinois, United States, 61637
United States, New York
Neurological Associate of Albany PC
Albany, New York, United States, 12208
United States, Texas
University of Texas Mental Sciences Institute
Houston, Texas, United States, 77030
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Holly Posner Eisai Inc.
  More Information

No publications provided

Responsible Party: Margaret Moline, Ph.D, Study Director, Eisai Inc.
ClinicalTrials.gov Identifier: NCT00165737     History of Changes
Other Study ID Numbers: E2020-A001-319
Study First Received: September 12, 2005
Last Updated: March 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
Dementia cerebrovascular disease

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

ClinicalTrials.gov processed this record on November 25, 2014