A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment

Phase 4

Completed

Conditions: Mild Cognitive Impairment

Interventions: Drug: placebo
Drug: Aricept (donepezil hydrochloride)

Registration Number: NCT00934375

Lead Sponsor: Eisai Inc.

Brief Summary: This is a multi-center, open-label study of 28 weeks duration in subjects with Mild Cognitive Impairment who have completed the double-blind study (E2020-A001-412).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 145

Inclusion Criteria

Age Range: Adult subjects (45 to 90 years of age inclusive)
Sex distribution: Men and women. Women of child-bearing potential (<1 year post menopausal) must be practicing effective contraception and have negative serum B-HCG at Screening. [Women who are breast-feeding are excluded.]
Subjects must have completed the one year, double-blind core trial (E2020-A001-412).
A completed Diagnostic Worksheet at the end of the double-blind core trial (E2020-A001-412) indicating no conversion to Alzheimer's Disease or dementia.
Health: Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane).
The subject must be expected to complete the entire study.
Subjects must be sufficiently fluent in English.
Subjects must have an informant who has daily contact with the subject (e.g., an average of 10 or more hours per week), can observe for possible adverse events and will accompany the subject to all visits.
Clinical laboratory values must be within normal limits, or if abnormal, judged clinically insignificant by the investigator (not likely to cause cognitive impairment or medical instability).

Exclusion Criteria

Subjects who have not completed or have terminated early from the one year, double-blind core trial (E2020-A001-412).
Any subject without a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412).
Any subject with a completed diagnostic worksheet from Week 51 of the core double-blind trial (E2020-A001-412) indicating conversion to Alzheimer's or other dementia.
Subjects with uncontrolled hypertension (sitting systolic >= 160mmHg and/or diastolic >=95mmHg) as assessed by the investigator, regardless of whether or not the subject is taking anti-hypertensive medications.
Subjects with a history of malignant neoplasms treated within five years prior to study entry (other than basal or squamous cell carcinoma of the skin); current evidence of malignant neoplasm; or recurrent or matastatic disease.
Subjects who have suffered a severe infection or a major surgical procedure within three months prior to baseline.
Subjects who may not be able to comply with the protocol.
Subjects with known hypersensitivity to piperidine derivatives or acetylcholinesterase(AChE)inhibitors.
Subjects with diabetes mellitis not controlled by diet and/or medication with a random serum glucose value of >170mg/dl.
Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
Subjects who do not have a reliable informant (e.g., the informant has contact with the subject less than 10 hours per week).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	Aricept (donepezil hydrochloride)	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Treatment-Emergent Adverse Events	Baseline, Week 6, Week 12 and Week 28.	Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (47): Pahl Pharmaceutical Research, LLC
🇺🇸
Oklahoma City, Oklahoma, United States
The University of Texas Mental Sciences Instittute
🇺🇸
Houston, Texas, United States
START Center
🇺🇸
San Antonio, Texas, United States
Neurology Neurodiagnostic Lab, LLC
🇺🇸
Alabaster, Alabama, United States
The Neurology Center
🇺🇸
Encinitas, California, United States
Comprehensive Neuroscience, Inc.
🇺🇸
St. Petersburg, Florida, United States
Sun Health Research Institute
🇺🇸
Sun City, Arizona, United States
Northwest Neurospecialists, PLLC
🇺🇸
Tucson, Arizona, United States
Optimum Health Services
🇺🇸
La Mesa, California, United States
Margolin Brain Institute
🇺🇸
Fresno, California, United States
Pivotal Research Centers
🇺🇸
Peoria, Arizona, United States
North Broward Medical Center Memory Disorder Center
🇺🇸
Deerfield Beach, Florida, United States
CA Neuroscience Research
🇺🇸
Sherman Oaks, California, United States
Nerve Pro Research
🇺🇸
Irvine, California, United States
Neurological Research Institute
🇺🇸
Santa Monica, California, United States
Colaborative Neuroscience Network (CNS Network)
🇺🇸
Garden Grove, California, United States
New York University School of Medicine Aging and Dementia Research Center
🇺🇸
New York, New York, United States
Neurological Associates of Albany, PC Neurology
🇺🇸
Albany, New York, United States
Neurology Center of Ohio
🇺🇸
Toledo, Ohio, United States
Westmoreland Neurology Associates
🇺🇸
Greensburg, Pennsylvania, United States
Neurobehavioral Research Inc.
🇺🇸
Lawrence, New York, United States
Clinical Trial Specialists
🇺🇸
Bala Cynwyd, Pennsylvania, United States
Columbia University
🇺🇸
New York, New York, United States
Summit Research Network(Oregon) Inc.
🇺🇸
Portland, Oregon, United States
Behavioral Medical Research of Staten Island
🇺🇸
Staten Island, New York, United States
Pacific Research Network
🇺🇸
Vista, California, United States
Berma Research Group
🇺🇸
Plantation, Florida, United States
Neurologic Consultants
🇺🇸
Ft. Lauderdale, Florida, United States
Wien Center for Memory Disorders, Mount Sinai Medical Center
🇺🇸
Miami Beach, Florida, United States
Center for Clinical Trials. L.C.
🇺🇸
Venice, Florida, United States
Lexington Clinic
🇺🇸
Lexington, Kentucky, United States
The Ohio State University
🇺🇸
Columbus, Ohio, United States
Southwestern Vermont Medical Center - The Memory Clinc
🇺🇸
Bennington, Vermont, United States
Grayline Clinical Drug Trials
🇺🇸
Wichita Falls, Texas, United States
St. Louis University - Clinical Trials Unit
🇺🇸
St. Louis, Missouri, United States
Sunrise Clinical Research
🇺🇸
Hollywood, Florida, United States
Monroe Community Hospital Program in Neurobehavioral Therapeutics
🇺🇸
Rochester, New York, United States
The Roskamp Institute
🇺🇸
Sarasota, Florida, United States
Comprehensive Neuroscience, Inc
🇺🇸
Kenilworth, New Jersey, United States
The Clinical Trial Center, LLC
🇺🇸
Jenkintown, Pennsylvania, United States
Palm Beach Neurology
🇺🇸
West Palm Beach, Florida, United States
Borgess Research Institute
🇺🇸
Kalamazoo, Michigan, United States
Stedman Clinical Trials, LLC
🇺🇸
Tampa, Florida, United States
USF Memory Disorder's Clinic
🇺🇸
Tampa, Florida, United States
USF Suncoast Gerontalogy Center
🇺🇸
Tampa, Florida, United States
Yale University Alzheimers Disease Research Unit School of Medicine Department of Psychiatry
🇺🇸
New Haven, Connecticut, United States
Medical University of South Carolina-Alzheimer's Research
🇺🇸
Charleston, South Carolina, United States