Intravenous Immune Globulin (IVIg) Study

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This study is currently enrolling participants.

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

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CLINICAL STUDY RESEARCH SITES PARTICIPATING IN THE IVIg STUDY

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