A 28-Week Open Label Extension Study Evaluating Safety and Tolerability of Donepezil Hydrochloride in Subjects With Mild Cognitive Impairment
1 other identifier
interventional
145
1 country
49
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2006
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
May 14, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedResults Posted
Study results publicly available
July 8, 2009
CompletedJanuary 14, 2014
December 1, 2013
1.6 years
May 14, 2009
July 25, 2011
December 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Treatment-Emergent Adverse Events
Overview of Treatment-Emergent Adverse Events and Safety Population (TEAEs)
Baseline, Week 6, Week 12 and Week 28.
Study Arms (2)
1
EXPERIMENTAL2
PLACEBO COMPARATORInterventions
5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (49)
Neurology Neurodiagnostic Lab, LLC
Alabaster, Alabama, 35007, United States
Pivotal Research Centers
Peoria, Arizona, 85381, United States
Sun Health Research Institute
Sun City, Arizona, 85351, United States
Northwest Neurospecialists, PLLC
Tucson, Arizona, 85741-3537, United States
The Neurology Center
Encinitas, California, 92024, United States
Margolin Brain Institute
Fresno, California, 93720, United States
Colaborative Neuroscience Network (CNS Network)
Garden Grove, California, 92845, United States
Nerve Pro Research
Irvine, California, 92618, United States
Optimum Health Services
La Mesa, California, 91942, United States
Pacific Research Network
San Diego, California, 92103, United States
Neurological Research Institute
Santa Monica, California, 90404, United States
CA Neuroscience Research
Sherman Oaks, California, 91403, United States
Pacific Research Network
Vista, California, 92081, United States
Yale University Alzheimers Disease Research Unit School of Medicine Department of Psychiatry
New Haven, Connecticut, 06510, United States
North Broward Medical Center Memory Disorder Center
Deerfield Beach, Florida, 33064, United States
Neurologic Consultants
Fort Lauderdale, Florida, 33308, United States
Berma Research Group
Hialeah, Florida, 33016, United States
Sunrise Clinical Research
Hollywood, Florida, 33021, United States
Wien Center for Memory Disorders, Mount Sinai Medical Center
Miami Beach, Florida, 33140, United States
Berma Research Group
Plantation, Florida, 33317, United States
The Roskamp Institute
Sarasota, Florida, 34243, United States
Comprehensive Neuroscience, Inc.
St. Petersburg, Florida, 33702, United States
Stedman Clinical Trials, LLC
Tampa, Florida, 33613, United States
USF Memory Disorder's Clinic
Tampa, Florida, 33613, United States
USF Suncoast Gerontalogy Center
Tampa, Florida, 33617, United States
Center for Clinical Trials. L.C.
Venice, Florida, 34285, United States
Palm Beach Neurology
West Palm Beach, Florida, 33407, United States
Lexington Clinic
Lexington, Kentucky, 40504, United States
Borgess Research Institute
Kalamazoo, Michigan, 49048, United States
St. Louis University - Clinical Trials Unit
St Louis, Missouri, 63104, United States
Comprehensive Neuroscience, Inc
Kenilworth, New Jersey, 07033, United States
Neurological Associates of Albany, PC Neurology
Albany, New York, 12208, United States
Neurobehavioral Research Inc.
Lawrence, New York, 11559, United States
New York University School of Medicine Aging and Dementia Research Center
New York, New York, 10016, United States
Columbia University
New York, New York, 10032, United States
Monroe Community Hospital Program in Neurobehavioral Therapeutics
Rochester, New York, 14620, United States
Behavioral Medical Research of Staten Island
Staten Island, New York, 10305, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Neurology Center of Ohio
Toledo, Ohio, 43623, United States
Pahl Pharmaceutical Research, LLC
Oklahoma City, Oklahoma, 73118, United States
Summit Research Network(Oregon) Inc.
Portland, Oregon, 97210, United States
Clinical Trial Specialists
Bala-Cynwyd, Pennsylvania, 19004, United States
Westmoreland Neurology Associates
Greensburg, Pennsylvania, 15601, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Medical University of South Carolina-Alzheimer's Research
Charleston, South Carolina, 29406, United States
The University of Texas Mental Sciences Instittute
Houston, Texas, 77030, United States
START Center
San Antonio, Texas, 78229-3900, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309, United States
Southwestern Vermont Medical Center - The Memory Clinc
Bennington, Vermont, 05201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Anita Murthy, Study Director
- Organization
- Eisai Inc.
Study Officials
- STUDY DIRECTOR
Anita Murthy
Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 14, 2009
First Posted
July 8, 2009
Study Start
February 1, 2006
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
January 14, 2014
Results First Posted
July 8, 2009
Record last verified: 2013-12