This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Donepezil Hydrochloride (E2020) in Dementia Associated With Cerebrovascular Disease

This study has been completed.
Information provided by:
Eisai Inc. Identifier:
First received: September 12, 2005
Last updated: March 31, 2011
Last verified: March 2011
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)

Ages Eligible for Study:   41 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00165737

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.
Study Director: Holly Posner Eisai Inc.
  More Information

Responsible Party: Margaret Moline, Ph.D, Study Director, Eisai Inc. Identifier: NCT00165737     History of Changes
Other Study ID Numbers: E2020-A001-319
Study First Received: September 12, 2005
Last Updated: March 31, 2011

Keywords provided by Eisai Inc.:
Dementia cerebrovascular disease

Additional relevant MeSH terms:
Cerebrovascular Disorders
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Vascular Diseases
Cardiovascular Diseases
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents processed this record on September 21, 2017