Phase 3 IGIV, 10% in Alzheimer´s Disease

• Cognitive subscale of the Alzheimer´s Disease Assessment Scale (ADAS-Cog) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
• Alzheimer´s Disease Cooperative Study (ADCS)-Activities of Daily Living (ADL) inventory [ Time Frame: 18 months ] [ Designated as safety issue: No ]

• ADCS-Clinical Global Impression of Change (CGIC) [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]
• Neuropsychiatric Inventory (NPI) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
• Change in volumetric magnetic resonance imaging (MRI) parameters [ Time Frame: Baseline and 18 months ] [ Designated as safety issue: No ]

The purpose of this study is to provide evidence of efficacy and safety to support the development of IGIV, 10% as a treatment option for patients with mild to moderate Alzheimer´s Disease.

• Biological: Immune Globulin Intravenous (Human), 10% Solution
  Intravenous infusion every 2 weeks over 18 months
  Other Name: IGIV, 10%
• Biological: Human albumin 0.25%
  Intravenous infusion every 2 weeks over 18 months

• Experimental: IGIV, 10% at Dose A (high dose)
  Intervention: Biological: Immune Globulin Intravenous (Human), 10% Solution
• Experimental: IGIV, 10% at Dose B (low dose)
  Intervention: Biological: Immune Globulin Intravenous (Human), 10% Solution
• Placebo Comparator: Placebo control
  Intervention: Biological: Human albumin 0.25%

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, or recent heart attack)
• 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.