Long-Term Study of IGIV, 10% in Alzheimer´s Disease
Condition: Alzheimer´s Disease
MeSH terms: Alzheimer Disease
Intervention: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 51 Years
Healthy volunteers: No

Summary:

      The purpose of this long-term study is to provide additional evidence of safety and efficacy
      of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase
      3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg
      or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701.
      Participants and investigators will be blinded to dose unless otherwise notified by the
      sponsor.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Completed 18 months of study treatment and assessments in Baxter precursor study
             160701

          -  Diagnosis of probable Alzheimer´s Disease (AD)

          -  Able to comply with testing and infusion regimen (including adequate corrected visual
             acuity and hearing ability)

          -  Has a caregiver (study partner) who is willing and able to participate

        Main Exclusion Criteria:

          -  Significant neurological disease other than AD

          -  Clinically significant cardiac/cardiovascular problems (e.g. uncontrolled blood
             pressure, atrial fibrillation, heart disease, clotting disorders, strokes, or recent
             heart attack)

          -  Contraindication to undergoing MRI (e.g. pacemaker [with the exception of an
             MRI-compatible pacemaker], severe claustrophobia, ferromagnetic implants such as a
             metal plate)

          -  Specific findings on brain MRI (microhemorrhages, superficial siderosis, vasogenic
             edema, 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

          -  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 immunomodulatory therapies (with the exception of
             immunoglobulin and non-systemic and low-dose systemic corticosteroids)

          -  Recent use of investigational drugs or biologics, including those aimed at altering AD
             progression (with the exception of immunoglobulin)

          -  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.