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| Sponsor: | Janssen, LP |
|---|---|
| Information provided by: | National Institute on Aging (NIA) |
| ClinicalTrials.gov Identifier: | NCT00000172 |
Purpose
Galantamine is an experimental drug being evaluated in the United States for the treatment of Alzheimer's disease. Results from previous clinical trials suggest that galantamine may improve cognitive performance in individuals with Alzheimer's disease. It is not a cure for Alzheimer's disease. Nerve cells in the brain responsible for memory and cognitive function communicate using a chemical called acetylcholine. Research has shown that deterioration of cells that produce acetylcholine in the brain affects thought processes. Galantamine is thought to work in two ways to increase the amount of acetylcholine available in the brain. It inhibits an enzyme that breaks down acetylcholine and it also stimulates the nicotinic receptors in the brain to release more acetylcholine.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease |
Drug: Galantamine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Official Title: | Placebo Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy Under a Slow-Titration Regimen |
After a 1-month single-blind run in phase, 910 subjects will be titrated, over a period of up to 8 weeks, to target doses of either: 0 (placebo); 24 mg/day galantamine; 16 mg/day galantamine; or 8 mg/day galantamine, in a 2:2:2:1 randomization ratio. Double-blind treatment will continue for a total of 5 months. The change from baseline in ADAS-cog and CIVIC-plus scores at Month 5 will be the primary efficacy endpoints. Tolerability will be evaluated based on adverse event reports, laboratory values, ECG, and vital signs with particular focus on the adverse event rates in the slower titration schedule for 24 mg/day. Efficacy of 24 mg/day and 16 mg/day galantamine will be compared with that of placebo. Information on the dose response relationship of galantamine will be evaluated.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama, Birmingham | |
| Birmingham, Alabama, United States, 35294-0017 | |
| United States, Arizona | |
| James L. Frey, M.D., Ltd. | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| Affiliated Research Institute | |
| San Diego, California, United States, 92108 | |
| N. County Neurology Assoc. | |
| Oceanside, California, United States, 92056 | |
| INC | |
| San Diego, California, United States, 92122 | |
| East Bay Neurology | |
| Berkeley, California, United States, 94705 | |
| Pacific Research Network (PRN) | |
| San Diego, California, United States, 92103 | |
| University of California Irvine Medical Center | |
| Orange, California, United States, 92868 | |
| University of Southern California | |
| Los Angeles, California, United States, 90033-1039 | |
| United States, Colorado | |
| The Denver Center for Medical Research | |
| Denver, Colorado, United States, 80212 | |
| United States, Connecticut | |
| Geriatric and Adult Psychiatry | |
| Hamden, Connecticut, United States, 06518 | |
| Yale University, School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| Neurological Research Institute of Sarasota, PA | |
| Sarasota, Florida, United States, 34239 | |
| Ocala Neurodiagnostic Center | |
| Ocala, Florida, United States, 34471 | |
| Premiere Research Institute | |
| West Palm Beach, Florida, United States, 33407 | |
| Psychiatric Institute of Florida | |
| Orlando, Florida, United States, 32806 | |
| Suncoast Neuroscience Associates, Inc. | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, Illinois | |
| Chicago Center for Clinical Research | |
| Chicago, Illinois, United States, 606104234 | |
| OSF Center for Senior Health | |
| Peoria, Illinois, United States, 616033089 | |
| United States, Indiana | |
| Indiana Alzheimer's University Clinic | |
| Indianapolis, Indiana, United States, 46202-5111 | |
| United States, Maryland | |
| The Johns Hopkins Hospital | |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| University of Massachusetts Worcester | |
| Worcester, Massachusetts, United States, 01655 | |
| Boston Clinical Research Center | |
| Wellesley Hills, Massachusetts, United States, 02481 | |
| Brigham Behavioral Neurology Group | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Michigan Medical P.C. | |
| Grand Rapids, Michigan, United States, 49503 | |
| Oakwood Hospital and Medical Center | |
| Dearborn, Michigan, United States, 48124 | |
| United States, Minnesota | |
| Regions Hospital | |
| St. Paul, Minnesota, United States, 55101 | |
| United States, Missouri | |
| St. Louis University School of Medicine | |
| St. Louis, Missouri, United States, 63104 | |
| Washington University | |
| St. Louis, Missouri, United States, 63108 | |
| United States, Nebraska | |
| University of Nebraska | |
| Omaha, Nebraska, United States, 681985575 | |
| United States, New Jersey | |
| Medwise Center | |
| West Long Branch, New Jersey, United States, 07764 | |
| Overlook Hospital | |
| Summit, New Jersey, United States, 07901 | |
| University of Medicine and Dentistry of New Jersey | |
| Piscataway, New Jersey, United States, 088551392 | |
| Neurology Group of Bergen County | |
| Ridgewood, New Jersey, United States, 07450 | |
| United States, New York | |
| East End Neuropsychiatric Associates | |
| Centereach, New York, United States, 11720 | |
| Neurological Associates of Albany, PC | |
| Albany, New York, United States, 12208 | |
| NYU Medical Center | |
| New York, New York, United States, 10016 | |
| St. John's Episcopal Hospital | |
| Far Rockaway, New York, United States, 11691 | |
| SUNY Stony Brook | |
| Stony Brook, New York, United States, 11794-8121 | |
| University of Rochester | |
| Rochester, New York, United States, 14620 | |
| United States, Ohio | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oklahoma | |
| Clinical Pharmaceutical Trials | |
| Tulsa, Oklahoma, United States, 741025428 | |
| United States, Oregon | |
| Oregon Health Sciences University | |
| Portland, Oregon, United States, 97201-3098 | |
| Pacific NW Clinical Research Center | |
| Portland, Oregon, United States, 97201 | |
| United States, Pennsylvania | |
| Institute for Advanced Clinical Research | |
| Elkins Park, Pennsylvania, United States, 19027 | |
| Neuroscience Center of Westmoreland Neurology | |
| Greensburg, Pennsylvania, United States, 15601 | |
| United States, Rhode Island | |
| Brown University | |
| Pawtucket, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| Alzheimer's Research and Clinical Programs | |
| North Charleston, South Carolina, United States, 294066076 | |
| United States, Texas | |
| University of Texas | |
| Dallas, Texas, United States, 752359070 | |
| United States, Vermont | |
| Memory Disorder Center of Vermont | |
| Colchester, Vermont, United States, 05446 | |
| Southwestern Vermont Medical Center | |
| Bennington, Vermont, United States, 05201 | |
| United States, Virginia | |
| Prince William Neuroscience Center | |
| Manassas, Virginia, United States, 20010 | |
| Virginia Neuroscience Center | |
| Alexandria, Virginia, United States, 22304 | |
| United States, Washington | |
| VAPS Health Care System | |
| Seattle, Washington, United States, 98108 | |
| Seattle Clinical Research Center | |
| Seattle, Washington, United States, 98104 | |
More Information
| Study ID Numbers: | IA0009 |
| Study First Received: | October 29, 1999 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00000172 History of Changes |
| Health Authority: | Unspecified |
|
Alzheimer's disease Cholinergic agents Cholinergic agonists Cholinesterase inhibitors |
|
Parasympathomimetics Nootropic Agents Neurotransmitter Agents Galantamine Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Alzheimer Disease Nervous System Diseases Central Nervous System Diseases Enzyme Inhibitors Cholinergic Agents Brain Diseases |
Neurodegenerative Diseases Pharmacologic Actions Cholinesterase Inhibitors Delirium, Dementia, Amnestic, Cognitive Disorders Autonomic Agents Mental Disorders Therapeutic Uses Peripheral Nervous System Agents Dementia Tauopathies Central Nervous System Agents |
