Evaluation of Galantamine in the Treatment of Alzheimer's Disease

June 23, 2005 updated by: Janssen, LP

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen, LP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 29, 1999

First Submitted That Met QC Criteria

October 29, 1999

First Posted (Estimate)

November 1, 1999

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

November 1, 2002

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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