OHSU

Intravenous Immune Globulin Study

Randomized, Double-Blind, Placebo-Controlled, Two Dose-Arm, Parallel Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Mild-to-Moderate Alzheimer's Disease.

Principle Investigator:  Dr. Joseph Quinn

Sponsor:  Baxter Healthcare

Length: 82 weeks   Visits: 13 Clinic, 33 Home Infusions

Purpose:  The primary objective is to determine if treatment with IGIV, 10% every two weeks by infusion results in a significantly slower rate of decline of dementia symptoms in subjects with mild-to-moderate Alzheimer's Disease as compared to placebo, measured by the cognitive subscale of the ADAS-Cog and the ADCS-CGIC.  

Study design:  Subjects will be randomized to one of three treatment groups: 400 mg/kg body weight, 200 mg/kg body weight or placebo IV infusion every two weeks for a total of 36 infusions.  The first three infusions will take place in the clinic, subsequent infusions are preferred in home, given by a home infusion nurse at the discretion of the principle investigator.  Patients will undergo physical, neurological, cognitive, clinical and lab assessments.  Patients must also have an ECG and chest x-ray.  Patients will undergo MRIs or CT (if MRI contraindicated).  However, the first 60 patients in the trial must be able to tolerate additional MRIs in the early phase, for additional safety testing.  Sub-study includes optional LP.

Study Care and Reimbursement:  Study visits provided at no charge.

Seeking Volunteers:

  • Diagnosed with probable AD
  • MMSE 16 – 26 inclusive
  • Age 50 - 89
  • Has a study partner willing to accompany the subject to all visits
  • On stable doses of approved AD meds 90 days prior to screening

Contact: Lisa Loree, RN at 503-494-7615 or loree@ohsu.edu

If you are interested in volunteering for this study, please read the description of the study carefully. If you (or someone for whom you may be inquiring) meet the eligibility requirements as listed in the section entitled "Seeking Volunteers", please provide your contact information below. A study representative will contact you to discuss the study's requirements and guidelines.

Request for information

Randomized, Double-Blind, Placebo-Controlled, Two Dose-Arm, Parallel Study of the Safety and Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Mild-to-Moderate Alzheimer's Disease.