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

Completed · Phase 4 · Has a placebo group

Conditions studied: Mild Cognitive Impairment

In brief

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).

Key facts

Study ID

NCT00934375

Run by

Eisai Inc.

People needed

145

Starts

2006-02-01

Expected to finish

2007-09-01

Last updated by the study team

2014-01-14

Who can join

Age: 45 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

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).

Where it is running

• Neurology Neurodiagnostic Lab, LLC — Alabaster, Alabama, United States
• Pivotal Research Centers — Peoria, Arizona, United States
• Sun Health Research Institute — Sun City, Arizona, United States
• Northwest Neurospecialists, PLLC — Tucson, Arizona, United States
• The Neurology Center — Encinitas, California, United States
• Margolin Brain Institute — Fresno, California, United States
• Colaborative Neuroscience Network (CNS Network) — Garden Grove, California, United States
• Nerve Pro Research — Irvine, California, United States
• Optimum Health Services — La Mesa, California, United States
• Pacific Research Network — San Diego, California, United States
• Neurological Research Institute — Santa Monica, California, United States
• CA Neuroscience Research — Sherman Oaks, California, United States
• Pacific Research Network — Vista, California, United States
• Yale University Alzheimers Disease Research Unit School of Medicine Department of Psychiatry — New Haven, Connecticut, United States
• North Broward Medical Center Memory Disorder Center — Deerfield Beach, Florida, United States
• Neurologic Consultants — Fort Lauderdale, Florida, United States
• Berma Research Group — Hialeah, Florida, United States
• Sunrise Clinical Research — Hollywood, Florida, United States
• Wien Center for Memory Disorders, Mount Sinai Medical Center — Miami Beach, Florida, United States
• Berma Research Group — Plantation, Florida, United States
• The Roskamp Institute — Sarasota, Florida, United States
• Comprehensive Neuroscience, Inc. — St. Petersburg, Florida, 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

Full record on ClinicalTrials.gov

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