Effect of IVIG on Cerebral and Retinal Amyloid in Mild Cognitive Impairment Due to Alzheimer Disease
Condition: Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a proof of concept study to determine if changes in brain amyloid levels are evident
      three months after infusion of 0.4 g/kg of IVIG every 14 days x 5 infusions. Amyloid levels
      will be measured by Florbetapir PET and retinal scan.
    

Detailed description: 
      Study design:

      This is a single center, open label, proof of concept, out-patient study. Subjects will
      undergo Florbetapir PET and have retinal amyloid levels measured, receive an infusion of IVIG
      at 0.4 g/kg every 14 days for a total of five infusions, and repeat PET and retinal amyloid
      measures three months after the first infusion.

      Subject population:

      The study population will consist of male and female subjects diagnosed with mild cognitive
      impairment (MCI) due to Alzheimer disease (AD).

      Estimated study duration:

      The duration of each study subject is approximately 4 months, including one screening visit
      over a period of approximately 28 days, 5 days of infusions over a 2-month period of time,
      and a follow-up visit at 3 months after the first infusion.

      Description of study drug:

      Octagam is an FDA approved 10% human normal immunoglobulin solution ready for intravenous
      administration.

      Study drug dosage:

      The dose level of IVIG at 0.4 g/kg will be administered by IV infusion once every 14 days for
      two months.

      Concomitant therapy:

      Concomitant medications will be assessed at all study visits. Concomitant medications are
      prescribed or over-the-counter medications and should be consistent with the
      inclusion/exclusion criteria. Concomitant medication appropriate to the subject's condition
      may be prescribed during the course of the study with the exception of those listed above.

      Routine vaccinations (i.e., flu vaccination) with commercially available therapeutics are
      permitted but must not be given within four weeks before or after the administration of the
      study drug.

      Evaluations by visit:

      Screening procedures at visit 1 will take place up to 28 days prior to Visit 2 (Day 1)
      dosing. Screening labs and assessments will be performed during the screening period. The
      first dose of study drug is administered on Day 1. Visits 2 through 6 have a ±1 day window
      and occur every 14 days over two months. The investigator will determine if a subject is
      suitable to continue following a missed infusion. Visit 7 has a ±7 day window.

      All study screening data from Visit 1 including laboratory results must be reviewed for study
      eligibility prior to receiving first dose of study drug. Prior to infusion, a review of
      concomitant medications and AEs takes place. If the subject continues to be eligible for
      enrollment, the subject will be infused with study medication and will remain in the infusion
      clinic for at least 1 hour following the infusion for safety assessments on Visit 2 (Day 1),
      and 15 minutes for the subsequent visits.
    

Intervention name(s): Octagam 10%
Intervention type(s): Biological
Intervention description(s): FDA approved human normal immunoglobulin solution ready for intravenous administration
Intervention MeSH terms: gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Intervention model: Single Group Assignment
Intervention model description: This is a single center, open label, proof of concept, out-patient study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MCI, Alzheimer Disease, AD