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IGIV (GAP Study)

A Randomized, Double-Blinded, Placebo-Controlled, Two Dose-Arm, Parallel Study of the Safety and Effectiveness of Immune Globulin Intravenous for the Treatment of Mild to Moderate Alzheimer's Disease

Status:	Active and Recruiting
Eligible Population(s):	Alzheimer's Disease
GCO Number:	08-1326 IRB approved through 03/16/2010
Principal Investigator:	Hillel Grossman, MD
Study Coordinator:	George Marzloff

If you or a loved one is living with Alzheimer's, you may want to know about the Gammaglobulin Alzheimer's Partnership (GAP) Study: a clinical research study that's bringing people with Alzheimer's disease, their caregivers, doctors, and medical researchers together to evaluate an investigational drug for people with mild-to-moderate Alzheimer's disease.

The Gammaglobulin Alzheimer's Partnership (GAP) Study is designed to evaluate the effectiveness, safety, and tolerability of an investigational drug called Gammaglobulin - and to see if this investigational drug may slow the progression of Alzheimer's and its symptoms.

Gammaglobulin is a form of Immune Globulin Intravenous, or IGIV. IGIV has been approved by the FDA for use with other conditions, and doctors and medical researchers are now evaluating its effectiveness, safety, and tolerability when it is used for Alzheimer's disease. Researchers believe that IGIV may act on some of the underlying causes of Alzheimer's, instead of just on Alzheimer's symptoms.

In this study, IGIV will be evaluated alongside standard-of-care medications for Alzheimer's. Patients who participate in the study will continue taking their current Alzheimer's medications.

Participation in this study will last approximately 82 weeks. All participants receive the following, at no cost:

• Study drugs - either IGIV or placebo (an inactive substance designed to have no effect on health). Every participant will have a random, 2-in-3 chance of receiving IGIV.
• Study-related care and close monitoring, both at the study clinic and potentially at the participant's home.
• Study clinic visits, at which the participant's physical and psychological health will be evaluated.

Patients may be eligible to participate in the GAP Study if they:

• Are 50 to 89 years old.
• Have been diagnosed with probable mild-to-moderate Alzheimer's disease.
• Have a study partner (a spouse, child, sibling, or other caregiver) who can be present at every study visit to monitor the participant, and to help him or her complete key study procedures.