A Phase 3 Study Evaluating Safety and Effectiveness of Immune Globulin Intravenous (IGIV 10%) for the Treatment of Mild-to-Moderate Alzheimer´s Disease
Condition: Alzheimer´s Disease
MeSH terms: Alzheimer Disease
Intervention: Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 400 mg/kg; Immune Globulin Intravenous (Human), 10% (IGIV, 10%) 200 mg/kg; Placebo solution: Human Albumin 0.25% - 4 mL/kg; Placebo solution: Human Albumin 0.25% - 2 mL/kg
Intervention description: 400 mg/kg bodyweight every 2 weeks for 70 weeks; 200 mg/kg bodyweight every 2 weeks for 70 weeks; Placebo solution: 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks; Placebo solution: 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks
Intervention MeSH terms: Pharmaceutical Solutions; Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin; Immunoglobulin G
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 390.0
Sex: All
Minimum age: 50 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Alzheimer´s; Dementia; Dementia of Alzheimer Type; Immunoglobulins; Gammaglobulins; Immune Globulin Intravenous (IGIV); Intravenous Immune Globulin (IVIG); Antibodies; Amyloid; Immunotherapy

Summary:

      The purpose of this study was to evaluate the efficacy and safety of 2 doses of Immune
      Globulin Intravenous (IGIV), 10% administered every 2 weeks as an intravenous (IV) infusion
      compared with placebo in participants with mild to moderate Alzheimer's disease (AD).
    

Eligibility criteria:

        Main 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 regulatory authority 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

        Main 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