DEERFIELD (dpa-AFX) - Baxter International Inc. (BAX) provided an update on its clinical program evaluating the use of its Gammagard Liquid 10% [Immune Globulin Infusion (Human)], for the treatment of mild to moderate Alzheimer's disease. Gammagard Liquid is marketed as KIOVIG outside the United States and Canada. The company said that it plans to initiate a second, confirmatory Phase III trial in the first quarter of 2012, having satisfactorily completed a futility analysis in its first Phase III trial. The second Phase III trial is identical in design to the first Phase III trial, and will assess the safety and effectiveness of Gammagard Liquid as a potential treatment for signs and symptoms associated with Alzheimer's disease, the company said. It is a global, multi-center clinical trial that will enroll approximately 400 patients and is expected to take an estimated three years to complete. Approximately 80 centers in North America, Europe, Japan and Australia will participate in the study. The primary endpoint of the study is to evaluate the effectiveness of Gammagard Liquid 10% on preserving cognitive performance and functional activities in patients with mild to moderate Alzheimer's disease, as compared to standard of care, over an 18-month period.
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