Donepezil Hydrochloride (E2020) in Dementia Associated With Cerebrovascular Disease

• ClinicalTrials.gov Identifier: NCT00165737
• Recruitment Status: Completed
• First Posted: September 14, 2005
• Last Update Posted: April 1, 2011
• Sponsor: Eisai Inc.
• Information provided by: Eisai Inc.

Tracking Information

• First Submitted Date: September 12, 2005
• First Posted Date: September 14, 2005
• Last Update Posted Date: April 1, 2011
• Study Start Date: March 2003
• Actual Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 4, 2007): 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. ]
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• Brief Summary: Twenty-four week, prospective, randomized, double-blind, placebo-controlled, parallel-group study.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Dementia, Vascular
• Intervention: Drug: Donepezil Hydrochloride
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 31, 2011): 974
• Original Enrollment: Not Provided
• Actual Study Completion Date: June 2006
• Actual Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 41 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00165737
• Other Study ID Numbers: E2020-A001-319
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Margaret Moline, Ph.D, Study Director, Eisai Inc.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Eisai Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Holly Posner; Eisai Inc.

• PRS Account: Eisai Inc.
• Verification Date: March 2011