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Donepezil Hydrochloride (E2020) in Dementia Associated With Cerebrovascular Disease

Primary Purpose

Dementia, Vascular

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Donepezil Hydrochloride
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia, Vascular focused on measuring Dementia cerebrovascular disease

Eligibility Criteria

41 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Central Arkansas Research (CARE)
  • Comprehensive Neuroscience
  • St. Francis Medical Center
  • Neurological Associate of Albany PC
  • University of Texas Mental Sciences Institute

Outcomes

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).

Secondary Outcome Measures

Full Information

First Posted
September 12, 2005
Last Updated
March 31, 2011
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00165737
Brief Title
Donepezil Hydrochloride (E2020) in Dementia Associated With Cerebrovascular Disease
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 Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eisai Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Vascular
Keywords
Dementia cerebrovascular disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
974 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Donepezil Hydrochloride
Primary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holly Posner
Organizational Affiliation
Eisai Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Central Arkansas Research (CARE)
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
Comprehensive Neuroscience
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
St. Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Neurological Associate of Albany PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
University of Texas Mental Sciences Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

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Donepezil Hydrochloride (E2020) in Dementia Associated With Cerebrovascular Disease

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