Evaluation of Galantamine in the Treatment of Alzheimer's Disease

Completed · Phase 3

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT00000172

Run by

Janssen, LP

Last updated by the study team

2005-06-24

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• James L. Frey, M.D., Ltd. — Scottsdale, Arizona, United States
• East Bay Neurology — Berkeley, California, United States
• University of Southern California — Los Angeles, California, United States
• N. County Neurology Assoc. — Oceanside, California, United States
• University of California Irvine Medical Center — Orange, California, United States
• Pacific Research Network (PRN) — San Diego, California, United States
• Affiliated Research Institute — San Diego, California, United States
• INC — San Diego, California, United States
• The Denver Center for Medical Research — Denver, Colorado, United States
• Geriatric and Adult Psychiatry — Hamden, Connecticut, United States
• Yale University, School of Medicine — New Haven, Connecticut, United States
• Ocala Neurodiagnostic Center — Ocala, Florida, United States
• Psychiatric Institute of Florida — Orlando, Florida, United States
• Neurological Research Institute of Sarasota, PA — Sarasota, Florida, United States
• Suncoast Neuroscience Associates, Inc. — St. Petersburg, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Chicago Center for Clinical Research — Chicago, Illinois, United States
• OSF Center for Senior Health — Peoria, Illinois, United States
• Indiana Alzheimer's University Clinic — Indianapolis, Indiana, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Brigham Behavioral Neurology Group — Boston, Massachusetts, United States
• Boston Clinical Research Center — Wellesley Hills, Massachusetts, United States
• University of Massachusetts Worcester — Worcester, Massachusetts, United States
• Oakwood Hospital and Medical Center — Dearborn, Michigan, United States
• University of Alabama, Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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