Donepezil Hydrochloride (E2020) in 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: NCT00165737|
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 1, 2011
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Dementia, Vascular||Drug: Donepezil Hydrochloride||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||974 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||March 2003|
|Actual Primary Completion Date :||August 2005|
|Actual Study Completion Date :||June 2006|
- 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. ]
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, Learn About Clinical Studies.
|Ages Eligible for Study:||41 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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): NCT00165737
|United States, Arkansas|
|Central Arkansas Research (CARE)|
|Hot Springs, Arkansas, United States, 71913|
|United States, Florida|
|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|
|Study Director:||Holly Posner||Eisai Inc.|
|Responsible Party:||Margaret Moline, Ph.D, Study Director, Eisai Inc.|
|Other Study ID Numbers:||
|First Posted:||September 14, 2005 Key Record Dates|
|Last Update Posted:||April 1, 2011|
|Last Verified:||March 2011|
Dementia cerebrovascular disease
Central Nervous System Diseases
Nervous System Diseases
Intracranial Arterial Diseases
Arterial Occlusive Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs