Evaluation of Galantamine in the Treatment of Alzheimer's Disease

NCT ID: NCT00000172

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Galantamine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Janssen, LP

INDUSTRY

Sponsor Role lead

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama, Birmingham

Birmingham, Alabama, United States

Site Status

James L. Frey, M.D., Ltd.

Scottsdale, Arizona, United States

Site Status

East Bay Neurology

Berkeley, California, United States

Site Status

University of Southern California

Los Angeles, California, United States

Site Status

N. County Neurology Assoc.

Oceanside, California, United States

Site Status

University of California Irvine Medical Center

Orange, California, United States

Site Status

Pacific Research Network (PRN)

San Diego, California, United States

Site Status

Affiliated Research Institute

San Diego, California, United States

Site Status

INC

San Diego, California, United States

Site Status

The Denver Center for Medical Research

Denver, Colorado, United States

Site Status

Geriatric and Adult Psychiatry

Hamden, Connecticut, United States

Site Status

Yale University, School of Medicine

New Haven, Connecticut, United States

Site Status

Ocala Neurodiagnostic Center

Ocala, Florida, United States

Site Status

Psychiatric Institute of Florida

Orlando, Florida, United States

Site Status

Neurological Research Institute of Sarasota, PA

Sarasota, Florida, United States

Site Status

Suncoast Neuroscience Associates, Inc.

St. Petersburg, Florida, United States

Site Status

Premiere Research Institute

West Palm Beach, Florida, United States

Site Status

Chicago Center for Clinical Research

Chicago, Illinois, United States

Site Status

OSF Center for Senior Health

Peoria, Illinois, United States

Site Status

Indiana Alzheimer's University Clinic

Indianapolis, Indiana, United States

Site Status

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status

Brigham Behavioral Neurology Group

Boston, Massachusetts, United States

Site Status

Boston Clinical Research Center

Wellesley Hills, Massachusetts, United States

Site Status

University of Massachusetts Worcester

Worcester, Massachusetts, United States

Site Status

Oakwood Hospital and Medical Center

Dearborn, Michigan, United States

Site Status

Michigan Medical P.C.

Grand Rapids, Michigan, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

St. Louis University School of Medicine

St Louis, Missouri, United States

Site Status

Washington University

St Louis, Missouri, United States

Site Status

University of Nebraska

Omaha, Nebraska, United States

Site Status

University of Medicine and Dentistry of New Jersey

Piscataway, New Jersey, United States

Site Status

Neurology Group of Bergen County

Ridgewood, New Jersey, United States

Site Status

Overlook Hospital

Summit, New Jersey, United States

Site Status

Medwise Center

West Long Branch, New Jersey, United States

Site Status

Neurological Associates of Albany, PC

Albany, New York, United States

Site Status

East End Neuropsychiatric Associates

Centereach, New York, United States

Site Status

St. John's Episcopal Hospital

Far Rockaway, New York, United States

Site Status

NYU Medical Center

New York, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

SUNY Stony Brook

Stony Brook, New York, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Clinical Pharmaceutical Trials

Tulsa, Oklahoma, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

Site Status

Pacific NW Clinical Research Center

Portland, Oregon, United States

Site Status

Institute for Advanced Clinical Research

Elkins Park, Pennsylvania, United States

Site Status

Neuroscience Center of Westmoreland Neurology

Greensburg, Pennsylvania, United States

Site Status

Brown University

Pawtucket, Rhode Island, United States

Site Status

Alzheimer's Research and Clinical Programs

North Charleston, South Carolina, United States

Site Status

University of Texas

Dallas, Texas, United States

Site Status

Southwestern Vermont Medical Center

Bennington, Vermont, United States

Site Status

Memory Disorder Center of Vermont

Colchester, Vermont, United States

Site Status

Virginia Neuroscience Center

Alexandria, Virginia, United States

Site Status

Prince William Neuroscience Center

Manassas, Virginia, United States

Site Status

Seattle Clinical Research Center

Seattle, Washington, United States

Site Status

VAPS Health Care System

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 10971048 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IA0009

Identifier Type: -

Identifier Source: org_study_id