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Evaluation of Galantamine in the Treatment of Alzheimer's Disease

Information source: National Institute on Aging (NIA)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer Disease

Intervention: Galantamine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen, LP

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.

Clinical Details

Official title: Placebo Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy Under a Slow-Titration Regimen

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

University of Alabama, Birmingham, Birmingham, Alabama 35294-0017, United States

James L. Frey, M.D., Ltd., Scottsdale, Arizona 85258, United States

East Bay Neurology, Berkeley, California 94705, United States

University of Southern California, Los Angeles, California 90033-1039, United States

N. County Neurology Assoc., Oceanside, California 92056, United States

University of California Irvine Medical Center, Orange, California 92868, United States

Affiliated Research Institute, San Diego, California 92108, United States

INC, San Diego, California 92122, United States

Pacific Research Network (PRN), San Diego, California 92103, United States

The Denver Center for Medical Research, Denver, Colorado 80212, United States

Geriatric and Adult Psychiatry, Hamden, Connecticut 06518, United States

Yale University, School of Medicine, New Haven, Connecticut 06520, United States

Ocala Neurodiagnostic Center, Ocala, Florida 34471, United States

Psychiatric Institute of Florida, Orlando, Florida 32806, United States

Neurological Research Institute of Sarasota, PA, Sarasota, Florida 34239, United States

Suncoast Neuroscience Associates, Inc., St. Petersburg, Florida 33701, United States

Premiere Research Institute, West Palm Beach, Florida 33407, United States

Chicago Center for Clinical Research, Chicago, Illinois 606104234, United States

OSF Center for Senior Health, Peoria, Illinois 616033089, United States

Indiana Alzheimer's University Clinic, Indianapolis, Indiana 46202-5111, United States

The Johns Hopkins Hospital, Baltimore, Maryland 21287, United States

Brigham Behavioral Neurology Group, Boston, Massachusetts 02115, United States

Boston Clinical Research Center, Wellesley Hills, Massachusetts 02481, United States

University of Massachusetts Worcester, Worcester, Massachusetts 01655, United States

Oakwood Hospital and Medical Center, Dearborn, Michigan 48124, United States

Michigan Medical P.C., Grand Rapids, Michigan 49503, United States

Regions Hospital, St. Paul, Minnesota 55101, United States

St. Louis University School of Medicine, St. Louis, Missouri 63104, United States

Washington University, St. Louis, Missouri 63108, United States

University of Nebraska, Omaha, Nebraska 681985575, United States

University of Medicine and Dentistry of New Jersey, Piscataway, New Jersey 088551392, United States

Neurology Group of Bergen County, Ridgewood, New Jersey 07450, United States

Overlook Hospital, Summit, New Jersey 07901, United States

Medwise Center, West Long Branch, New Jersey 07764, United States

Neurological Associates of Albany, PC, Albany, New York 12208, United States

East End Neuropsychiatric Associates, Centereach, New York 11720, United States

St. John's Episcopal Hospital, Far Rockaway, New York 11691, United States

NYU Medical Center, New York, New York 10016, United States

University of Rochester, Rochester, New York 14620, United States

SUNY Stony Brook, Stony Brook, New York 11794-8121, United States

Ohio State University, Columbus, Ohio 43210, United States

Clinical Pharmaceutical Trials, Tulsa, Oklahoma 741025428, United States

Oregon Health Sciences University, Portland, Oregon 97201-3098, United States

Pacific NW Clinical Research Center, Portland, Oregon 97201, United States

Institute for Advanced Clinical Research, Elkins Park, Pennsylvania 19027, United States

Neuroscience Center of Westmoreland Neurology, Greensburg, Pennsylvania 15601, United States

Brown University, Pawtucket, Rhode Island 02906, United States

Alzheimer's Research and Clinical Programs, North Charleston, South Carolina 294066076, United States

University of Texas, Dallas, Texas 752359070, United States

Southwestern Vermont Medical Center, Bennington, Vermont 05201, United States

Memory Disorder Center of Vermont, Colchester, Vermont 05446, United States

Virginia Neuroscience Center, Alexandria, Virginia 22304, United States

Prince William Neuroscience Center, Manassas, Virginia 20010, United States

Seattle Clinical Research Center, Seattle, Washington 98104, United States

VAPS Health Care System, Seattle, Washington 98108, United States

Additional Information

Related publications:

Lilienfeld S, Parys W. Galantamine: additional benefits to patients with Alzheimer's disease. Dement Geriatr Cogn Disord. 2000 Sep;11 Suppl 1:19-27. Review.


Last updated: June 23, 2005

Page last updated: August 23, 2015

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