A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease

• Cognition and global function [ Time Frame: 18 months ] [ Designated as safety issue: No ]
• Activities of daily living, behavior, and quality of life [ Time Frame: 9 and 18 months ] [ Designated as safety issue: No ]

The purpose of this study is to determine whether IGIV, 10% treatment, administered at two different doses for 18 months, slows the rate or prevents the progression of dementia symptoms in subjects with mild to moderate Alzheimer´s Disease (AD). Subjects will be randomly assigned to receive intravenous infusions of either of two doses of IGIV, 10% or placebo every two weeks for 70 weeks (36 infusions) as an add-on to conventional Food and Drug Administration (FDA)-approved AD medications.

Study visits: Each subject 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 subject must return to the site every 3 months for evaluation of cognition as well as blood tests and scans of the brain.

• Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
  400 mg/kg bodyweight every 2 weeks for 70 weeks
  Other Name: Gammagard Liquid
• Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
  200 mg/kg bodyweight every 2 weeks for 70 weeks
  Other Name: Gammagard Liquid
• Other: Placebo solution
  4 or 2 mL/kg bodyweight every 2 weeks for 70 weeks

• Experimental: Group 1
  Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
  Intervention: Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
• Experimental: Group 2
  Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
  Intervention: Drug: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
• Placebo Comparator: Group 3
  Intervention: Other: Placebo solution

Inclusion Criteria:

• Written informed consent - subject (or 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 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 (Reasons why it might not be appropriate to participate):

• Any other forms of dementia

• Medical issues that might increase the risk of treatment with IGIV, 10%, such as:

  1. Significant problems with blood pressure, heart disease, clotting disorders, strokes or recent heart attacks
  2. Evidence of current bleeding in the brain by MRI
  3. Serious problems with the liver or kidneys
  4. Allergies to blood products

• Medical issues that might interfere with the evaluation of the treatment of dementia or might make dementia worse, such as:

  1. Diabetes
  2. Recent treatment with chemotherapy or immune suppression
  3. The recent use of other investigational drugs, especially antibody therapy for AD
  4. Severe headaches or psychiatric problems

There are other reasons why it might not be appropriate to participate in this trial. Please consult an investigator at one of the trial sites for details.