Evaluation of Galantamine in the Treatment of Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00000172
First received: October 29, 1999
Last updated: June 23, 2005
Last verified: November 2002
  Purpose

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.


Condition Intervention Phase
Alzheimer Disease
Drug: Galantamine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Placebo Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy Under a Slow-Titration Regimen

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000172

  Hide Study Locations
Locations
United States, Alabama
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294-0017
United States, Arizona
James L. Frey, M.D., Ltd.
Scottsdale, Arizona, United States, 85258
United States, California
East Bay Neurology
Berkeley, California, United States, 94705
University of Southern California
Los Angeles, California, United States, 90033-1039
N. County Neurology Assoc.
Oceanside, California, United States, 92056
University of California Irvine Medical Center
Orange, California, United States, 92868
Affiliated Research Institute
San Diego, California, United States, 92108
INC
San Diego, California, United States, 92122
Pacific Research Network (PRN)
San Diego, California, United States, 92103
United States, Colorado
The Denver Center for Medical Research
Denver, Colorado, United States, 80212
United States, Connecticut
Geriatric and Adult Psychiatry
Hamden, Connecticut, United States, 06518
Yale University, School of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Ocala Neurodiagnostic Center
Ocala, Florida, United States, 34471
Psychiatric Institute of Florida
Orlando, Florida, United States, 32806
Neurological Research Institute of Sarasota, PA
Sarasota, Florida, United States, 34239
Suncoast Neuroscience Associates, Inc.
St. Petersburg, Florida, United States, 33701
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Illinois
Chicago Center for Clinical Research
Chicago, Illinois, United States, 606104234
OSF Center for Senior Health
Peoria, Illinois, United States, 616033089
United States, Indiana
Indiana Alzheimer's University Clinic
Indianapolis, Indiana, United States, 46202-5111
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham Behavioral Neurology Group
Boston, Massachusetts, United States, 02115
Boston Clinical Research Center
Wellesley Hills, Massachusetts, United States, 02481
University of Massachusetts Worcester
Worcester, Massachusetts, United States, 01655
United States, Michigan
Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48124
Michigan Medical P.C.
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Regions Hospital
St. Paul, Minnesota, United States, 55101
United States, Missouri
St. Louis University School of Medicine
St. Louis, Missouri, United States, 63104
Washington University
St. Louis, Missouri, United States, 63108
United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 681985575
United States, New Jersey
University of Medicine and Dentistry of New Jersey
Piscataway, New Jersey, United States, 088551392
Neurology Group of Bergen County
Ridgewood, New Jersey, United States, 07450
Overlook Hospital
Summit, New Jersey, United States, 07901
Medwise Center
West Long Branch, New Jersey, United States, 07764
United States, New York
Neurological Associates of Albany, PC
Albany, New York, United States, 12208
East End Neuropsychiatric Associates
Centereach, New York, United States, 11720
St. John's Episcopal Hospital
Far Rockaway, New York, United States, 11691
NYU Medical Center
New York, New York, United States, 10016
University of Rochester
Rochester, New York, United States, 14620
SUNY Stony Brook
Stony Brook, New York, United States, 11794-8121
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Oklahoma
Clinical Pharmaceutical Trials
Tulsa, Oklahoma, United States, 741025428
United States, Oregon
Oregon Health Sciences University
Portland, Oregon, United States, 97201-3098
Pacific NW Clinical Research Center
Portland, Oregon, United States, 97201
United States, Pennsylvania
Institute for Advanced Clinical Research
Elkins Park, Pennsylvania, United States, 19027
Neuroscience Center of Westmoreland Neurology
Greensburg, Pennsylvania, United States, 15601
United States, Rhode Island
Brown University
Pawtucket, Rhode Island, United States, 02906
United States, South Carolina
Alzheimer's Research and Clinical Programs
North Charleston, South Carolina, United States, 294066076
United States, Texas
University of Texas
Dallas, Texas, United States, 752359070
United States, Vermont
Southwestern Vermont Medical Center
Bennington, Vermont, United States, 05201
Memory Disorder Center of Vermont
Colchester, Vermont, United States, 05446
United States, Virginia
Virginia Neuroscience Center
Alexandria, Virginia, United States, 22304
Prince William Neuroscience Center
Manassas, Virginia, United States, 20010
United States, Washington
VAPS Health Care System
Seattle, Washington, United States, 98108
Seattle Clinical Research Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
Janssen, LP
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000172     History of Changes
Other Study ID Numbers: IA0009
Study First Received: October 29, 1999
Last Updated: June 23, 2005
Health Authority: Unspecified

Keywords provided by National Institute on Aging (NIA):
Alzheimer's disease
Cholinergic agents
Cholinergic agonists
Cholinesterase inhibitors

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Galantamine
Cholinergic Agonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014