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Alzheimer DiseasePhase 3NCT00000172

Evaluation of Galantamine in the Treatment of Alzheimer's Disease

A Phase 3 study testing Galantamine in people with Alzheimer Disease, run by Janssen, LP at 55 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 0 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
Galantamine
How many people
Not given
Where
55 sitesUnited States
Study dates
Start not givento not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

55 sites in 1 country.

55 sites in 1 country

United States55 sites

  • Neurological Associates of Albany, PC

    Albany, New York, 12208

  • Virginia Neuroscience Center

    Alexandria, Virginia, 22304

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Southwestern Vermont Medical Center

    Bennington, Vermont, 05201

  • East Bay Neurology

    Berkeley, California, 94705

  • University of Alabama, Birmingham

    Birmingham, Alabama, 35294-0017

  • Brigham Behavioral Neurology Group

    Boston, Massachusetts, 02115

  • East End Neuropsychiatric Associates

    Centereach, New York, 11720

  • Chicago Center for Clinical Research

    Chicago, Illinois, 606104234

  • Memory Disorder Center of Vermont

    Colchester, Vermont, 05446

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas

    Dallas, Texas, 752359070

  • Oakwood Hospital and Medical Center

    Dearborn, Michigan, 48124

  • The Denver Center for Medical Research

    Denver, Colorado, 80212

  • Institute for Advanced Clinical Research

    Elkins Park, Pennsylvania, 19027

  • St. John's Episcopal Hospital

    Far Rockaway, New York, 11691

  • Michigan Medical P.C.

    Grand Rapids, Michigan, 49503

  • Neuroscience Center of Westmoreland Neurology

    Greensburg, Pennsylvania, 15601

  • Geriatric and Adult Psychiatry

    Hamden, Connecticut, 06518

  • Indiana Alzheimer's University Clinic

    Indianapolis, Indiana, 46202-5111

  • University of Southern California

    Los Angeles, California, 90033-1039

  • Prince William Neuroscience Center

    Manassas, Virginia, 20010

  • Yale University, School of Medicine

    New Haven, Connecticut, 06520

  • NYU Medical Center

    New York, New York, 10016

  • Alzheimer's Research and Clinical Programs

    North Charleston, South Carolina, 294066076

  • Ocala Neurodiagnostic Center

    Ocala, Florida, 34471

  • N. County Neurology Assoc.

    Oceanside, California, 92056

  • University of Nebraska

    Omaha, Nebraska, 681985575

  • University of California Irvine Medical Center

    Orange, California, 92868

  • Psychiatric Institute of Florida

    Orlando, Florida, 32806

  • Brown University

    Pawtucket, Rhode Island, 02906

  • OSF Center for Senior Health

    Peoria, Illinois, 616033089

  • University of Medicine and Dentistry of New Jersey

    Piscataway, New Jersey, 088551392

  • Oregon Health Sciences University

    Portland, Oregon, 97201-3098

  • Pacific NW Clinical Research Center

    Portland, Oregon, 97201

  • Neurology Group of Bergen County

    Ridgewood, New Jersey, 07450

  • University of Rochester

    Rochester, New York, 14620

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • Pacific Research Network (PRN)

    San Diego, California, 92103

  • Affiliated Research Institute

    San Diego, California, 92108

  • INC

    San Diego, California, 92122

  • Neurological Research Institute of Sarasota, PA

    Sarasota, Florida, 34239

  • James L. Frey, M.D., Ltd.

    Scottsdale, Arizona, 85258

  • Seattle Clinical Research Center

    Seattle, Washington, 98104

  • VAPS Health Care System

    Seattle, Washington, 98108

  • St. Louis University School of Medicine

    St Louis, Missouri, 63104

  • Washington University

    St Louis, Missouri, 63108

  • Suncoast Neuroscience Associates, Inc.

    St. Petersburg, Florida, 33701

  • SUNY Stony Brook

    Stony Brook, New York, 11794-8121

  • Overlook Hospital

    Summit, New Jersey, 07901

  • Clinical Pharmaceutical Trials

    Tulsa, Oklahoma, 741025428

  • Boston Clinical Research Center

    Wellesley Hills, Massachusetts, 02481

  • Medwise Center

    West Long Branch, New Jersey, 07764

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • University of Massachusetts Worcester

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Galantamine
Keywords
Alzheimer's disease, Cholinergic agents, Cholinergic agonists, Cholinesterase inhibitors
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GalantamineDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 1999 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
IDs, dates and publications
ClinicalTrials.gov ID
NCT00000172
Sponsor's protocol ID
IA0009
Status last verified
Nov 2002
First submitted
29 Oct 1999
Last updated
24 Jun 2005
Results posted
No

Publications

  • 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.

    PubMed 10971048

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Galantamine in people with Alzheimer Disease, run by Janssen, LP at 55 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00000172, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.

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