New York-Presbyterian Hospital Weill Cornell Medical Centre and Baxter International Inc. has announced results of a six-month, placebo-controlled phase II study of 24 patients treated with Gammagard S/D and Gammagard Liquid for the treatment of mild-to-moderate Alzheimer's disease at the American Academy of Neurology (AAN) annual meeting in Chicago.

The study met the primary endpoint criteria favouring Gammagard Liquid and Gammagard S/D over placebo on measures of cognitive function and global impression of change, which are common measures of outcome in Alzheimer's disease clinical trials. The study also met secondary endpoints that measured changes in beta-amyloid and anti-amyloid antibody levels in blood and cerebrospinal fluid. Results show findings indicative of potential efficacy and tolerability.

"This was the first placebo-controlled clinical trial of Gammagard for Alzheimer's disease and the results are clearly promising," Dr Relkin commented. Baxter supported the study and provided Gammagard Liquid and Gammagard S/D for the trial. Gammagard S/D and Gammagard Liquid, marketed as KIOVIG in the European Union, contain a broad spectrum of immunoglobulins (antibodies) and are indicated as an immunoglobulin replacement therapy that boosts the immune system in patients with primary immunodeficiency disorders. The precise mechanisms of Gammagard S/D and Gammagard Liquid's effects in Alzheimer's disease are not known.

"These study results reflect Baxter's support of innovative science and commitment to meeting a critical, unmet medical need," said Hartmut J Ehrlich, MD, vice president of global research and development for Baxter's BioScience business. "While results of Baxter's mid-stage development work in Alzheimer's disease treatment are promising, further investigation in a larger phase III study is required".