Phase 3 IGIV, 10% in Alzheimer´s Disease

Main Inclusion Criteria:

• Written informed consent - subject (or the subject'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 screening
• Neuroimaging performed after symptom onset consistent with AD diagnosis
• On stable doses of AD medication(s) for at least 12 weeks 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

Main Exclusion Criteria:

• Possible AD or non-AD dementia
• Current residence in a skilled nursing facility
• Contraindication to undergoing MRI (eg pacemaker, severe claustrophobia, ferromagnetic implants such as a metal plate)
• Clinically significant cardiovascular problems (e.g. uncontrolled blood pressure, heart disease, clotting disorders, strokes, atrial fibrillation, unstable angina (angina at rest) or recent heart attack)
• Clinically significant congestive heart failure (e.g. New York Heart Association [NYHA] Class III/IV symptoms or untreated Class II)
• History of thrombosis and/or thromboembolic disease (central or peripheral) within the 12 months prior to screening
• Specific findings on brain MRI (microhemorrhages, superficial siderosis, a macrohemorrhage, major stroke, or multiple lacunae)
• Active malignancy or history of malignancy within 5 years prior to screening with the exception of the following: adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, and stable prostate cancer not requiring treatment
• Active autoimmune or neuro-immunologic disorder
• Uncontrolled major depression, psychosis, or other major psychiatric disorder(s)
• Poorly controlled diabetes
• Serious problems with liver or kidneys
• Known history of hypersensitivity following infusions of human blood or blood components (e.g. human immunoglobulins or human albumin)
• Current or recent treatment with immunoglobulin and/or immunomodulatory therapies
• Recent use of investigational drugs or biologics, including those aimed at altering AD progression
• Active immunization for the treatment of AD at any time

There are reasons why it might not be appropriate to participate in this trial.

Please contact Medical Information at medinfo@baxter.com for details.