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Home > "E" Clinical Trials Conditions > Evaluation of Galantamine in the Treatment of Alzheimer's Disease  Evaluation of Galantamine in the Treatment of Alzheimer's Disease
Evaluation of Galantamine in the Treatment of Alzheimer's Disease
For Condition: Alzheimer Disease
Status: Completed
Sponsor(s): Janssen Pharmaceutica ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - Probable Alzheimer's disease - Mini-Mental State Examination (MMSE) 10-22 and ADAS greater than or equal to 18 - Alzheimer's Disease Assessment Scale cognitive portion (ADAS-cog-11) score of at least 18 - Opportunity for Activities of Daily Living - Caregiver - Subjects who live with or have regular daily visits from a responsible caregiver (visit frequency: preferably daily but at least 5 days/week). This includes a friend or relative or paid personnel. The caregiver should be capable of assisting with the subject's medication, prepared to attend with the subject for assessments, and willing to provide information about the subject. Exclusion Criteria: - Conditions that could confound diagnosis - Neurodegenerative disorders - Acute cerebral trauma - Psychiatric disease - More than one infarct on CT/MRI scans - History of alcohol or drug abuse - Contradictions for a cholinominetic agent: seizures; ulcers; pulmonary conditions (including severe asthma); unstable angina; Afib; bradycardia less than 50; and AV block.
Total Enrollment:
Location and Contact Information:
East Bay Neurology
Berkeley, California, 94705
United States
University of California Irvine Medical Center
Orange, California, 92868
United States
Chicago Center for Clinical Research
Chicago, Illinois, 606104234
United States
Indiana Alzheimer's University Clinic
Indianapolis, Indiana, 46202-5111
United States
Prince William Neuroscience Center
Manassas, Virginia, 20010
United States
University of Alabama, Birmingham
Birmingham, Alabama, 35294-0017
United States
James L. Frey, M.D., Ltd.
Scottsdale, Arizona, 85258
United States
Geriatric and Adult Psychiatry
Hamden, Connecticut, 06518
United States
Michigan Medical P.C.
Grand Rapids, Michigan, 49503
United States
Overlook Hospital
Summit, New Jersey, 07901
United States
East End Neuropsychiatric Associates
Centereach, New York, 11720
United States
Oregon Health Sciences University
Portland, Oregon, 97201-3098
United States
N. County Neurology Assoc.
Oceanside, California, 92056
United States
Yale University, School of Medicine
New Haven, Connecticut, 06520
United States
Southwestern Vermont Medical Center
Bennington, Vermont, 05201
United States
OSF Center for Senior Health
Peoria, Illinois, 616033089
United States
Pacific NW Clinical Research Center
Portland, Oregon, 97201
United States
Alzheimer's Research and Clinical Programs
North Charleston, South Carolina, 294066076
United States
University of Texas
Dallas, Texas, 752359070
United States
Regions Hospital
St. Paul, Minnesota, 55101
United States
Washington University
St. Louis, Missouri, 63108
United States
Ohio State University
Columbus, Ohio, 43210
United States
Clinical Pharmaceutical Trials
Tulsa, Oklahoma, 741025428
United States
INC
San Diego, California, 92122
United States
University of Massachusetts Worcester
Worcester, Massachusetts, 01655
United States
Boston Clinical Research Center
Wellesley Hills, Massachusetts, 02481
United States
Pacific Research Network (PRN)
San Diego, California, 92103
United States
University of Medicine and Dentistry of New Jersey
Piscataway, New Jersey, 088551392
United States
Psychiatric Institute of Florida
Orlando, Florida, 32806
United States
Neurological Associates of Albany, PC
Albany, New York, 12208
United States
St. John's Episcopal Hospital
Far Rockaway, New York, 11691
United States
Neuroscience Center of Westmoreland Neurology
Greensburg, Pennsylvania, 15601
United States
University of Rochester
Rochester, New York, 14620
United States
Memory Disorder Center of Vermont
Colchester, Vermont, 05446
United States
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, 33701
United States
Medwise Center
West Long Branch, New Jersey, 07764
United States
Affiliated Research Institute
San Diego, California, 92108
United States
Brown University
Pawtucket, Rhode Island, 02906
United States
Premiere Research Institute
West Palm Beach, Florida, 33407
United States
Seattle Clinical Research Center
Seattle, Washington, 98104
United States
Virginia Neuroscience Center
Alexandria, Virginia, 22304
United States
Neurological Research Institute of Sarasota, PA
Sarasota, Florida, 34239
United States
Oakwood Hospital and Medical Center
Dearborn, Michigan, 48124
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
SUNY Stony Brook
Stony Brook, New York, 11794-8121
United States
University of Southern California
Los Angeles, California, 90033-1039
United States
Ocala Neurodiagnostic Center
Ocala, Florida, 34471
United States
St. Louis University School of Medicine
St. Louis, Missouri, 63104
United States
University of Nebraska
Omaha, Nebraska, 681985575
United States
Institute for Advanced Clinical Research
Elkins Park, Pennsylvania, 19027
United States
Brigham Behavioral Neurology Group
Boston, Massachusetts, 02115
United States
Neurology Group of Bergen County
Ridgewood, New Jersey, 07450
United States
The Denver Center for Medical Research
Denver, Colorado, 80212
United States
NYU Medical Center
New York City, New York, 10016
United States
VAPS Health Care System
Seattle, Washington, 98108
United States
Additional Information:
Study ID Numbers: IA0009;
Study Start Date:
Record last reviewed: November 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000172
Other Alzheimer Disease Studies:
1. Insulin, Neurogentics and Memory in Alzheimer's Disease
2. Treatment of Behavioral Symptoms in Alzheimer's Disease
3. Prevention of Alzheimer's Disease by Vitamin E and Selenium (PREADVISE)
4. Electrophysiologic Measures of Treatment Response in Alzheimer Disease
5. ALADDIN Study
Related Studies:
Other Alzheimer Disease Clinical Trials
Other Illinois Clinical Trials
Other Peoria Clinical Trials
Evaluation of Galantamine in the Treatment of Alzheimer's Disease
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