Mar 26, 2010

Intravenous Immune Globulin (IVIg) -- Phase 3 Clinical Trial

This 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.

By Bob DeMarco
Alzheimer's Reading Room

Note: Update -- Baxter GAMMAGARD in Patients with Alzheimer's Disease Shows Promise

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
  • 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

For more information and the list of locations -- go here.

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Original content Bob DeMarco, the Alzheimer's Reading Room