Evaluation of Galantamine in the Treatment of Alzheimer's Disease
Placebo Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy Under a Slow-Titration Regimen
1 other identifier
interventional
N/A
1 country
55
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 1999
CompletedFirst Posted
Study publicly available on registry
November 1, 1999
CompletedJune 24, 2005
November 1, 2002
October 29, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen, LPlead
Study Sites (55)
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
Pacific Research Network (PRN)
San Diego, California, 92103, United States
Affiliated Research Institute
San Diego, California, 92108, United States
INC
San Diego, California, 92122, 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
Saint 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
Related Publications (1)
Lilienfeld S, Parys W. Galantamine: additional benefits to patients with Alzheimer's disease. Dement Geriatr Cogn Disord. 2000 Sep;11 Suppl 1:19-27. doi: 10.1159/000051228.
PMID: 10971048BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 29, 1999
First Posted
November 1, 1999
Last Updated
June 24, 2005
Record last verified: 2002-11