''The signals identified in the clinical and biological markers in select subgroups in this analysis are intriguing and help contribute to a better understanding of this disease,'' said Norman Relkin, MD, PhD, from Weill Cornell Medical College and GAP Study leader.
Pre-planned and exploratory analyses on the GAP study findings are ongoing, including reviews of subgroups and compilation of volumetric MRI imaging data, and will be presented at a major medical meeting in the fall.
''We are currently collaborating with scientific experts in the field of Alzheimer’s research to further explore these findings,'' said Ludwig Hantson, Ph.D., President of Baxter’s BioScience business.
About the GAP Study
The GAP study was the largest placebo-controlled study of immunoglobulin, and was designed to assess the safety and effectiveness of Baxter’s IG as a potential treatment for signs and symptoms associated with Alzheimer’s disease. The clinical trial included 390 patients with mild to moderate Alzheimer’s disease across 45 centers in the U.S. and Canada. Patients were randomized to receive Baxter’s IG at either 400 mg/kg or 200 mg/kg dosing every two weeks for 18 months, or placebo. All patients were required to maintain their treatment regimen of approved medications for Alzheimer’s disease symptom management.
About Alzheimer’s Disease
Alzheimer’s disease (AD) is the most common type of dementia, a general term for memory loss and other intellectual abilities serious enough to interfere with daily life. The neurodegenerative disease is characterized by progressive cognitive, functional, and behavioral impairment. Alzheimer’s is now the sixth leading cause of death in the United States, with more than five million people living with the disease today.
Immunoglobulin (IG) is made from purified human plasma, which is collected from healthy volunteers. The immunoglobulin in plasma contains human antibodies that protect the body against infection, offering important immunomodulatory and anti-inflammatory properties that help treat rare immune-related and neurological conditions. IG treatment is administered on an ongoing basis to help patients maintain adequate levels of antibodies. IG has been investigated as a treatment for Alzheimer’s disease and is not approved for use in the treatment of the disease.