Baxter’s Gammagard Shows Promise in AD

Baxter International and New York-Presbyterian Hospital/Weill Cornell Medical Center achieved positive results from an 18-month Phase II study of Gammagard Liquid and Gammagard S/D [Immune Globulin Intravenous (Human)] in mild-to-moderate Alzheimer’s disease.

The study measured function and cognition using the Alzheimer’s Disease Cooperative Study-Clinical Global Impression of Change rating (ADCS-CGIC) and the Alzheimer’s Disease Assessment Scale-Cognitive Subscale score (ADAS-Cog). After 18 months, patients who received Gammagard continuously averaged approximately 1.36 points higher for function than patients who received placebo. For cognition, patients who received Gammagard declined by approximately 9.15 fewer points than patients who received placebo.

Additionally, MRI analyses showed that patients who received Gammagard experienced decreased mean annual ventricular enlargement rates in their brains (6.7%), compared to placebo (12.3%). Patients who received Gammagard also experienced lower mean annual whole brain atrophy rates (-1.58%) compared to placebo (-2.24%).

Baxter plans to initiate a second Phase III study of Gammagard for mild-to-moderate Alzheimer’s disease to confirm the Phase II results in more patients. The Phase II results represent the first study in Alzheimer’s disease where all three measures – cognitive, functional and neuroimaging – had positive data and were statistically significant.