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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000172
Other study ID # IA0009
Secondary ID
Status Completed
Phase Phase 3
First received October 29, 1999
Last updated June 23, 2005

Study information

Verified date November 2002
Source National Institute on Aging (NIA)
Contact n/a
Is FDA regulated No
Health authority Unspecified
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Galantamine


Locations

Country Name City State
United States Neurological Associates of Albany, PC Albany New York
United States Virginia Neuroscience Center Alexandria Virginia
United States The Johns Hopkins Hospital Baltimore Maryland
United States Southwestern Vermont Medical Center Bennington Vermont
United States East Bay Neurology Berkeley California
United States University of Alabama, Birmingham Birmingham Alabama
United States Brigham Behavioral Neurology Group Boston Massachusetts
United States East End Neuropsychiatric Associates Centereach New York
United States Chicago Center for Clinical Research Chicago Illinois
United States Memory Disorder Center of Vermont Colchester Vermont
United States Ohio State University Columbus Ohio
United States University of Texas Dallas Texas
United States Oakwood Hospital and Medical Center Dearborn Michigan
United States The Denver Center for Medical Research Denver Colorado
United States Institute for Advanced Clinical Research Elkins Park Pennsylvania
United States St. John's Episcopal Hospital Far Rockaway New York
United States Michigan Medical P.C. Grand Rapids Michigan
United States Neuroscience Center of Westmoreland Neurology Greensburg Pennsylvania
United States Geriatric and Adult Psychiatry Hamden Connecticut
United States Indiana Alzheimer's University Clinic Indianapolis Indiana
United States University of Southern California Los Angeles California
United States Prince William Neuroscience Center Manassas Virginia
United States Yale University, School of Medicine New Haven Connecticut
United States NYU Medical Center New York New York
United States Alzheimer's Research and Clinical Programs North Charleston South Carolina
United States Ocala Neurodiagnostic Center Ocala Florida
United States N. County Neurology Assoc. Oceanside California
United States University of Nebraska Omaha Nebraska
United States University of California Irvine Medical Center Orange California
United States Psychiatric Institute of Florida Orlando Florida
United States Brown University Pawtucket Rhode Island
United States OSF Center for Senior Health Peoria Illinois
United States University of Medicine and Dentistry of New Jersey Piscataway New Jersey
United States Oregon Health Sciences University Portland Oregon
United States Pacific NW Clinical Research Center Portland Oregon
United States Neurology Group of Bergen County Ridgewood New Jersey
United States University of Rochester Rochester New York
United States Affiliated Research Institute San Diego California
United States INC San Diego California
United States Pacific Research Network (PRN) San Diego California
United States Neurological Research Institute of Sarasota, PA Sarasota Florida
United States James L. Frey, M.D., Ltd. Scottsdale Arizona
United States Seattle Clinical Research Center Seattle Washington
United States VAPS Health Care System Seattle Washington
United States St. Louis University School of Medicine St. Louis Missouri
United States Washington University St. Louis Missouri
United States Regions Hospital St. Paul Minnesota
United States Suncoast Neuroscience Associates, Inc. St. Petersburg Florida
United States SUNY Stony Brook Stony Brook New York
United States Overlook Hospital Summit New Jersey
United States Clinical Pharmaceutical Trials Tulsa Oklahoma
United States Boston Clinical Research Center Wellesley Hills Massachusetts
United States Medwise Center West Long Branch New Jersey
United States Premiere Research Institute West Palm Beach Florida
United States University of Massachusetts Worcester Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Janssen, LP

Country where clinical trial is conducted

United States, 

References & 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. Review. — View Citation

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