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	Treatment or Intervention	Phase
Alzheimer Disease	Drug: Galantamine	Phase III

Further Study Details: 

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.

Genders Eligible for Study:  Both

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.

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

Study ID Numbers:  IA0009
Record last reviewed:  November 2002
Last Updated:  October 13, 2004
Record first received:  October 29, 1999
ClinicalTrials.gov Identifier:  NCT00000172
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08