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Sponsored by: |
Novartis |
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Information provided by: | National Institute on Aging (NIA) |
ClinicalTrials.gov Identifier: | NCT00000174 |
This phase IIIb trial is a prospective, randomized, double-blind, placebo-controlled, 36-month study comparing the length of time of progression from mild cognitive impairment (MCI) to a clinical diagnosis of Alzheimer's disease (AD) in subjects taking Exelon vs. placebo. Exelon is currently under review with the U.S. Food and Drug Administration as a treatment for Alzheimer's disease. The drug has been cleared for marketing in more than 40 countries for Alzheimer's disease to date, including all 15 member states of the European Union, New Zealand, Argentina, Brazil and Mexico.
Each subject with MCI will be randomly assigned to treatment with either Exelon or placebo. Subjects assigned to Exelon will receive 1.5 to 6.0 mg bid (twice daily) (3.0 to 12 mg/day) for the majority of the study. At every regular visit scheduled every three months, patients will be given basic efficacy and safety assessments. These assessments will include evaluation of adverse events, vital signs, activities of daily living, and clinical staging scales to determine if the subject may have converted to dementia.
Condition | Intervention | Phase |
---|---|---|
Alzheimer Disease Cognition Disorders |
Drug: Rivastigmine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Ages Eligible for Study: | 55 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Arizona | |
Medici Research Centers | |
Peoria, Arizona, United States, 85381 | |
United States, California | |
University of California, Irvine | |
Orange, California, United States, 92868 | |
United States, Colorado | |
University of Colorado Health Sciences Center | |
Denver, Colorado, United States, 80220 | |
United States, Florida | |
Center for Clinical Trials and Research | |
Venice, Florida, United States, 34285 | |
Miami Research Associates | |
Miami, Florida, United States, 33176 | |
Neuromedical Research Institute (Offices in Ft. Lauderdale, Miami Beach and Boca Raton) | |
Ft. Lauderdale, Florida, United States, 33321 | |
United States, Indiana | |
Indiana University Alzheimer's Center | |
Indianapolis, Indiana, United States, 46202 | |
United States, Missouri | |
St. Louis University | |
St. Louis, Missouri, United States, 63104 | |
United States, New Jersey | |
Alzheimer's Research Corporation | |
Lakewood, New Jersey, United States, 08701 | |
United States, New York | |
NYU Medical Center | |
New York, New York, United States, 10016 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Oklahoma | |
Pahl Brain Associates, P.C. | |
Oklahoma City, Oklahoma, United States, 73118 | |
United States, Pennsylvania | |
Clinical Studies, Ltd., Philadelphia | |
Philadelphia, Pennsylvania, United States, 19106 | |
United States, Texas | |
St. Paul Medical Center | |
Dallas, Texas, United States, 75235 | |
United States, Washington | |
University of Washington, Seattle | |
Seattle, Washington, United States, 98108 |
Principal Investigator: | Steven Ferris, PhD | New York University School of Medicine |
Study ID Numbers: | IA0012 |
Study First Received: | October 29, 1999 |
ClinicalTrials.gov Identifier: | NCT00000174 |
Health Authority: | Unspecified |
Mild cognitive impairment Alzheimer's disease Memory Cholinergic agents Cholinesterase inhibitors |
Delirium, Dementia, Amnestic, Cognitive Disorders Rivastigmine Mental Disorders Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Brain Diseases Dementia Cognition Disorders Delirium |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs Enzyme Inhibitors Cholinergic Agents Neuroprotective Agents |
Protective Agents Pharmacologic Actions Cholinesterase Inhibitors Therapeutic Uses Tauopathies Central Nervous System Agents |