Evaluation of Galantamine in the Treatment of Alzheimer's Disease
- Conditions
- Alzheimer Disease
- Registration Number
- NCT00000172
- Lead Sponsor
- Janssen, LP
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (55)
University of Southern California
๐บ๐ธLos Angeles, California, United States
VAPS Health Care System
๐บ๐ธSeattle, Washington, United States
Indiana Alzheimer's University Clinic
๐บ๐ธIndianapolis, Indiana, United States
Pacific Research Network (PRN)
๐บ๐ธSan Diego, California, United States
Affiliated Research Institute
๐บ๐ธSan Diego, California, United States
The Denver Center for Medical Research
๐บ๐ธDenver, Colorado, United States
Oregon Health Sciences University
๐บ๐ธPortland, Oregon, United States
Pacific NW Clinical Research Center
๐บ๐ธPortland, Oregon, United States
N. County Neurology Assoc.
๐บ๐ธOceanside, California, United States
The Johns Hopkins Hospital
๐บ๐ธBaltimore, Maryland, United States
Ocala Neurodiagnostic Center
๐บ๐ธOcala, Florida, United States
Neurological Research Institute of Sarasota, PA
๐บ๐ธSarasota, Florida, United States
Clinical Pharmaceutical Trials
๐บ๐ธTulsa, Oklahoma, United States
SUNY Stony Brook
๐บ๐ธStony Brook, New York, United States
Neuroscience Center of Westmoreland Neurology
๐บ๐ธGreensburg, Pennsylvania, United States
University of Alabama, Birmingham
๐บ๐ธBirmingham, Alabama, United States
East Bay Neurology
๐บ๐ธBerkeley, California, United States
James L. Frey, M.D., Ltd.
๐บ๐ธScottsdale, Arizona, United States
Geriatric and Adult Psychiatry
๐บ๐ธHamden, Connecticut, United States
INC
๐บ๐ธSan Diego, California, United States
University of California Irvine Medical Center
๐บ๐ธOrange, California, United States
OSF Center for Senior Health
๐บ๐ธPeoria, Illinois, United States
Suncoast Neuroscience Associates, Inc.
๐บ๐ธSt. Petersburg, Florida, United States
Chicago Center for Clinical Research
๐บ๐ธChicago, Illinois, United States
Brigham Behavioral Neurology Group
๐บ๐ธBoston, Massachusetts, United States
Boston Clinical Research Center
๐บ๐ธWellesley Hills, Massachusetts, United States
Regions Hospital
๐บ๐ธSt. Paul, Minnesota, United States
University of Massachusetts Worcester
๐บ๐ธWorcester, Massachusetts, United States
Michigan Medical P.C.
๐บ๐ธGrand Rapids, Michigan, United States
Oakwood Hospital and Medical Center
๐บ๐ธDearborn, Michigan, United States
St. Louis University School of Medicine
๐บ๐ธSt. Louis, Missouri, United States
Washington University
๐บ๐ธSt. Louis, Missouri, United States
University of Medicine and Dentistry of New Jersey
๐บ๐ธPiscataway, New Jersey, United States
Neurology Group of Bergen County
๐บ๐ธRidgewood, New Jersey, United States
Overlook Hospital
๐บ๐ธSummit, New Jersey, United States
Medwise Center
๐บ๐ธWest Long Branch, New Jersey, United States
Neurological Associates of Albany, PC
๐บ๐ธAlbany, New York, United States
St. John's Episcopal Hospital
๐บ๐ธFar Rockaway, New York, United States
NYU Medical Center
๐บ๐ธNew York, New York, United States
University of Rochester
๐บ๐ธRochester, New York, United States
Ohio State University
๐บ๐ธColumbus, Ohio, United States
Institute for Advanced Clinical Research
๐บ๐ธElkins Park, Pennsylvania, United States
Brown University
๐บ๐ธPawtucket, Rhode Island, United States
Alzheimer's Research and Clinical Programs
๐บ๐ธNorth Charleston, South Carolina, United States
University of Texas
๐บ๐ธDallas, Texas, United States
Memory Disorder Center of Vermont
๐บ๐ธColchester, Vermont, United States
Virginia Neuroscience Center
๐บ๐ธAlexandria, Virginia, United States
Prince William Neuroscience Center
๐บ๐ธManassas, Virginia, United States
Seattle Clinical Research Center
๐บ๐ธSeattle, Washington, United States
East End Neuropsychiatric Associates
๐บ๐ธCentereach, New York, United States
Premiere Research Institute
๐บ๐ธWest Palm Beach, Florida, United States
Southwestern Vermont Medical Center
๐บ๐ธBennington, Vermont, United States
Yale University, School of Medicine
๐บ๐ธNew Haven, Connecticut, United States
Psychiatric Institute of Florida
๐บ๐ธOrlando, Florida, United States
University of Nebraska
๐บ๐ธOmaha, Nebraska, United States