The study met the primary endpoint criteria favoring 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. Results show findings indicative of potential efficacy and tolerability.
The study also met secondary endpoints that measured changes in beta-amyloid and anti-amyloid antibody levels in blood and cerebrospinal fluid. Secondary endpoint results suggest that levels of antibodies against beta-amyloid were observed to have increased in the blood and cerebrospinal fluid of patients treated with Gammagard S/D and Gammagard Liquid, while the levels of beta-amyloid increased in the blood. Beta-amyloid is a substance thought to contribute to the degeneration.
Hartmut Ehrlich, vice president of global R&D for Baxter’s BioScience business, said: “While results of company’s mid-stage development work in Alzheimer’s disease treatment are promising, further investigation in a larger Phase III study is required.”