The ongoing Phase III study of GAMMAGARD, called the Gammaglobulin Alzheimer's Partnership (GAP) Study, is designed to evaluate the potential of GAMMAGARD for mild-to-moderate Alzheimer's disease. The study includes 35 actively enrolling sites at leading academic centers in the United States that are members of The Alzheimer's Disease Cooperative Study (ADCS), with an additional 12 sites pending in the U.S. and Canada. Study participants will be evaluated on clinical scales for cognition and function over 18 months. Biomarker and neuroimaging tests will be performed in order to measure GAMMAGARD's potential effect on disease progression. Alzheimer's patients and their caregivers can find study details and learn more about participation by visiting www.GAPSTUDY or calling 1-877-55-GAPSTUDY (1-877-554-2778). The study is sponsored by Baxter and partially funded by the National Institutes of Health (NIH) through the Alzheimer's Disease Cooperative Study (ADCS).
Baxter plans to initiate a second, concurrent 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.
"Baxter is encouraged by the 18-month Phase II results for GAMMAGARD for Alzheimer's disease. Based on the strength of these data, we plan to initiate a second Phase III study of GAMMAGARD for Alzheimer's disease," said Hartmut Ehrlich, M.D., vice president of research and development for Baxter BioScience. "The new study will collect additional evidence to support GAMMAGARD's use in mild-to-moderate Alzheimer's disease and, with our ongoing Phase III study, support filing for registration in this indication. We will work closely with FDA on appropriate next steps and look forward to making continued progress studying GAMMAGARD's potential benefit in Alzheimer's disease and other neurology indications."
Baxter's commitment to advancing the scientific and clinical knowledge around GAMMAGARD in several neurological applications includes multiple late-stage clinical trials. In addition to the ongoing Phase III trial studying GAMMAGARD LIQUID in Alzheimer's disease, Baxter is currently enrolling patients into a Phase III trial studying GAMMAGARD LIQUID in multifocal motor neuropathy (MMN). A Phase III trial studying GAMMAGARD LIQUID in chronic inflammatory demyelinating polyneuropathy (CIDP) is planned to begin later this year.
SOURCE Baxter International Inc.,