Qualifications for this Study

Inclusion Criteria:

• Written informed consent - participant (or participant´s legally acceptable representative) and caregiver who are willing and able to participate for the duration of the study
  
• Diagnosis of probable Alzheimer´s Disease (AD)
  
• Dementia of mild to moderate severity defined as mini-mental state examination (MMSE) 16-26 inclusive at the time of screening
  
• Neuroimaging (computed tomography [CT] or MRI) performed after symptom onset consistent with AD diagnosis
  
• Ability to comply with testing and infusion regimen, including fluency in English or Spanish, adequate corrected visual acuity and hearing ability
  
• On stable doses of FDA approved AD medication(s) for at least 3 months prior to screening. These medications must be continued throughout this study.
  
• If receiving psychoactive medications (e.g. antidepressants other than monoamine oxidase inhibitors (MAOIs) and most tricyclics, antipsychotics, anxiolytics, anticonvulsants, mood stabilizers, etc), must be on stable doses for at least 6 weeks prior to screening

Exclusion Criteria:

• Any other forms of dementia
  
• Medical issues that might increase the risk of treatment with IGIV, 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
  
  There are other reasons why it might not be appropriate to pariticipate in this trial. Please consult an investigator at one of the trial sites for details.

Prohibited Medications:

• Taking immunosuppressive drugs
  
• 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 IGIV treatment within the 5 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

Study Description

Since the late 1990s, there has been increasing evidence that immunotherapy targeting the amyloid beta (Aβ) peptide can be used to treat AD. This study aims to evaluate the use of Immune Globulin Intravenous (Human), 10% [IGIV, 10%] that is approved in the United States to treat various immunodeficiency and autoimmune disorders. IGIV contains antibodies that bind to oligomeric and fibrillar beta amyloid, thus supporting the rationale of studying IGIV as an agent for passive immunotherapy of AD. Passive immunization does not require the recipients to produce antibodies themselves and can thereby circumvent the problem of inadequate antibody generation by older individuals. Unlike active vaccination, T-cell activation is not required to realize the full therapeutic benefits of passive immunization. Passive immunization could therefore provide a safer and effective alternative to active vaccination for the treatment of elderly AD patients.

Study visits: Each participant will be tested at the investigational site, and if qualified, will be treated intravenously (through a vein) every two weeks for 70 weeks (approximately 18 months). The first three infusions must be done at the site, but if the infusions are well tolerated, subsequent infusions may be done by a qualified healthcare provider in the home or other suitable location. Each participant must return to the site every 3 months for evaluation of cognition as well as blood tests and scans of the brain.

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