Clinical Trials

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

Description

Status: Closed to Enrollment

Start Date: Dec 17 2008

End Date: OPEN

Objective:

To determine whether IGIV, 10% treatment either at a dose of 400 mg/kg body weight (BW)/2 weeks or 200 mg/ kg BW/2 weeks for 9 months results in a significantly slower rate of decline of dementia symptoms in subjects with mild-to-moderate Alzheimer’s Disease (AD) as compared to placebo, as measured by the cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-Cog) and the Alzheimer’s Disease Cooperative Study (ADCS)-Clinical Global Impression of Change (ADCS-CGIC).

Inclusion Criteria:

  1. Patients with mild-to-moderate dementia; probable Alzheimer’s disease (AD)
  2. Age 50-89, inclusive
  3. Neuroimaging consistent with AD diagnosis
  4. Ability to comply with testing and infusion regimen
  5. On stable doses of FDA-approved AD medications
  6. Suitable venous access
  7. Stable doses of psychoactive medications

Exclusion Criteria:

Subjects will be excluded if they meet any of the following criteria:

  1. Possible AD
  2. Non-community dwelling
  3. Clinically significant concurrent condition (congestive heart failure; uncontrolled hypertension; malignancy; autoimmune or neuro-immunologic disorder; poorly controlled diabetes; untreated major depression; active renal disease; active migraines or frequent headaches; significantly abnormal blood chemistry/hematology; positive serology for HBsAg, Hepatitic C, HIV, IgA deficiency), or history of unstable angina, myocardial infarction, thrombosis, or head trauma within 12 months prior to screening.
  4. Known history of procoagulant abnormalities
  5. History of intracerebral hemorrhage within 5 years prior to screening
  6. Evidence of 2 or more microhemorrhages, major stroke, or multiple lacunae
  7. Uncontrolled seizure disorder
  8. Modified Hachinski score >4 at screen
  9. Known history of allergic reaction to albumin
  10. IgA deficiency
  11. Treatment with immunosuppressive drugs

Principal Investigators

Richard King, M.D.

Contact Information

Name: Richard King, MD, PhD
Phone: (801) 587-7888
Email:

Please Note:

Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a University of Utah doctor or clinic location to meet your health care needs.

Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.

The information posted on this site is consistent with the research reviewed and approved by the University of Utah Institutional Review Board (IRB). However, the IRB has not reviewed all material posted on this site. Contact the IRB if you have questions regarding your rights as a research participant. Also contact the IRB if you have questions, complaint, or concerns which you do not feel you can discuss with the investigator. The University of Utah IRB may be reached by phone at (801) 581-3655 or by e-mail at irb@hsc.utah.edu.