Evaluation of Galantamine in the Treatment of Alzheimer's Disease

Alzheimer Disease Clinical Trial

Official title:

Placebo Controlled Evaluation of Galantamine in the Treatment of Alzheimer's Disease: Safety and Efficacy Under a Slow-Titration Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00000172
• Other study ID #: IA0009
• 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
• 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

• Alzheimer Disease

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