Who May be Eligible to Participate in the GAP Study?
Patients may be eligible to participate in the GAP Study if they:
- Are 50 to 89 years old
- Have been diagnosed with probable mild-to-moderate Alzheimer's disease
- Have a study partner (a spouse, child, sibling, or other caregiver) who can be present at every study visit to monitor the participant, and to help him or her complete key study procedures
- Have good venous access for repeated infusion and blood draws
- Are fluent in English or Spanish
- Are in good general health
Patients may not be eligible to participate in the GAP Study if they:
- Have any other forms of dementia
- Have medical issues that might increase the risk of treatment with IVIg, 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
- Have 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 drugs
- The recent use of other investigational drugs, especially antibody therapy for AD
- Severe headaches or psychiatric problems
- Use non-steroidal anti-inflammatory drugs (NSAIDs) more than 3 times weekly (with the exception of aspirin daily), or are currently receiving or has received any immunomodulating therapies within 3 months prior to screening
- Are currently receiving or has received IVIg treatment within five years prior to screening
- Are 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
- Have current or recent (within 3 months prior to screening) participation in any other investigational drug or device studies
- Are taking immunosuppressive drugs
You or the person in your care 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 about additional study sites and for information on dementia and aging, go to
http://www.alzheimers.org\clinicaltrials\fullrec.asp?PrimaryKey=282
See if you May be Eligible to Participate
To see if you or someone in your care may be able to participate, please call 1-800.438.4380 and mention the GAP Study
Whether or not you or someone in your care decide to participate in the GAP Study, we encourage you to speak with your doctor or other healthcare professionals to learn more about the treatment and support options available to you.
