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Alzheimer’s Disease Cooperative Study

INTRAVENOUS IMMUNE GLOBULIN (IVIG) STUDY

This is an ongoing study closed to enrollment.
Intravenous Immune Globulin (IVIg) has been approved and used successfully for over 20 years to treat a variety of autoimmune and immunodeficient diseases. Since the late 1990s, there has been increasing evidence that immunotherapy targeting the amyloid beta (Aβ) peptide can be used to treat Alzheimer’s disease (AD). Because it contains anti-amyloid antibodies IVIg is being investigated in a Phase III study as a treatment for Alzheimer’s disease.

Two previous studies showed statistical improvement in cognition while reducing amyloid levels in the brain, thought to contribute to AD development. IVIg contains antibodies that bind to oligomeric and fibrillar beta amyloid. This provides a justification for studying IVIg as a means for passive immunotherapy of AD. Passive immunization might provide a successful alternative to active amyloid vaccination for the treatment of AD.

The Phase III double-blind, placebo-controlled study, called GAP (Gammaglobulin Alzheimer’s Partnership) Study is further examining the safety, effectiveness and tolerability of IVIg in mild to moderate AD patients. GAP is recruiting 360 participants at approximately 38 sites nationwide. The study will last a maximum of 82 weeks. Two-thirds of participants will receive IVIg and one-third will get placebo. Sites are looking for study volunteers who fit the following criteria:

Male or female, 50-89 years old
Have been diagnosed with probable mild to moderate Alzheimer’s disease.
Have a study partner (spouse, child, sibling or friend) in contact with the participant 10 hours/week or more
Good venous access for repeated infusion and blood draws
Fluent in English or Spanish
In good general health
Exclusions:

Any other forms of dementia
Medical issues that might increase the risk of treatment with IVIg, 10%, such as:
Significant problems with blood pressure, heart disease, clotting disorders, strokes or recent heart attacks
Evidence of current bleeding in the brain by MRI
Serious problems with the liver or kidneys
Allergies to blood products
Medical issues that might interfere with the evaluation of the treatment of dementia or might make dementia worse, such as:
Diabetes
Recent treatment with chemotherapy or immune suppression
The recent use of other investigational drugs, especially antibody therapy for AD
Severe headaches or psychiatric problems
Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) more than 3 times weekly (with the exception of aspirin daily), or currently receiving or has received any immunomodulating therapies within 3 months prior to screening
Currently receiving or has received IVIg treatment within five years prior to screening
Currently receiving or has received any investigational biologic(s) (e.g. active immunization or passive immunotherapies with monoclonal or polyclonal antibodies) for AD at any time, or any investigational drug(s) for AD within 3 months prior to screening
Current or recent (within 3 months prior to screening) participation in any other investigational drug or device studies.
Taking immunosuppressive drugs
Participants will be tested at research sites and if they qualify will be treated intravenously every two weeks for 18 months (70 weeks). The first three infusions will occur at the research site. If they are well tolerated successive infusions may be done by a healthcare professional at the participants’ homes or other appropriate locations.

To learn how to participate in the study, contact NIA’s Alzheimer’s Disease Education and Referral (ADEAR) Center at 1-800-438-4380 or by email to adear@nia.nih.gov. To view a list of the research sites or for information on dementia and aging, go to

U.S. CLINICAL STUDY RESEARCH SITES PARTICIPATING IN THE IVIg STUDY
You can sort the Site name, City or Phone number by click one of the column titles.
Site Location Telephone #
Banner Alzheimer Institute Phoenix, Arizona 602-839-6900
Banner Sun Health Research Institute Sun City, Arizona 623-875-6522
Bronson Lakeview Psychiatry Kalamazoo, Michigan 269-341-8774
Cleveland Clinic Lou Ruvo Center for Brain Health Las Vegas, Nevada 702-483-6025
Columbia University New York, New York 212-305-7661
Georgetown University Washington, District of Columbia 202-687-8800
Mayo Clinic, Rochester Rochester, Minnesota 507-284-7906
Medical University South Carolina Charleston, South Carolina 843-740-1592
Mount Sinai School of Medicine New York, New York 212-241-1514
Neurological Care of CNY Syracuse, New York 315-701-4554
New York University New York, New York 212-263-5845
Oregon Health & Science University Portland, Oregon 503-494-7615
Psychiatric Consultants Nashville, Tennessee 615-807-4023
Rhode Island Hospital Providence, Rhode Island 401-444-1743
St. Louis University St. Louis, Missouri 314-977-4818
Synergy Clinical Research Center National City, California 619-327-0155
Tulsa Clinical Research Tulsa, Oklahoma 918-743-2349
University Hospitals Case Medical Center Cleveland, Ohio 216-464-6412
University of Alabama at Birmingham Birmingham, Alabama 205-934-6223
University of Arizona Health Sciences Center Tucson, Arizona 520-626-4296
University of California, Irvine – Alzheimer’s Disease Research Center Irvine, California 949-824-3250
University of California, Irvine (BIC) Orange, California 714-456-7994
University of California, San Diego – Alzheimer’s Clinical Center La Jolla, California 858-246-1305
University of Iowa Memory Disorders Clinic Iowa City, Iowa 319-353-5158
University of Kansas Alzheimer & Memory Program Kansas City, Kansas 913-588-0555
University of Kentucky Lexington, Kentuckey 859-257-1412 ext 234
University of Nebraska Medical Center Omaha, Nebraska 402-552-6005
University of Pennsylvania Philadelphia, Pennsylvania 215-615-3084
University of South Florida Tampa, Florida 813-974-4355
University of Southern California Los Angeles, California 323-442-7600
University of Texas Southwestern Dallas, Texas 214-648-0255
University of Utah Salt Lake City, Utah 801-587-8385
University of Wisconsin Madison, Wisconsin 1-866-MEM-PROG
Weill Cornell Memory Disorders Program New York, New York 212-746-6581
Wien Center for Clinical Research Miami, Florida 305-674-2424
Yale University Alzheimer’s Disease Research Unit New Haven, Connecticut 203-764-8100

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~ by Butch on September 23, 2012.

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