Scientists to test gammaglobulin treatment for Alzheimer’s disease
Initial research in experimental models and patients suggest that immunotherapy targeting the beta-amyloid (the protein that forms the plaques in the brain) may provide a more effective way to treat AD. The antibodies that bind to the beta-amyloid is present in IVIG, which is made from the blood of thousands of healthy adults.
One characteristic of Alzheimer’s pathology is the abundance of beta-amyloid deposits in the brain. While it remains unclear whether beta-amyloid plaques cause AD or are a byproduct of the disease, scientists are interested in finding ways to reduce the toxic effects of beta-amyloid in the brain. The antibodies against amyloid beta may do so by binding to toxic forms of amyloid beta, which neutralize and / or promoting their elimination.
“We are investigating whether IVIG, which naturally contains human anti-amyloid antibodies, will defend the brain of AD patients against the harmful effects of beta-amyloid. If it does, giving IVIG to patients with mild to moderate Alzheimer’s disease can potentially reduce the rate of disease progression, “says Alan Lerner, MD, principal investigator of the study in Cleveland and director of the Center for Memory and Cognition.
“In our initial studies in AD patients, IGIV provide important cognitive benefits, improves cerebral metabolism and reduction of beta-amyloid levels in cerebrospinal fluid,” says Norman Relkin, MD, project director and director of the Disease Alzheimer’s and Weill Cornell Memory Disorders Program. In a phase II trial at Weill Cornell, Dr. Relkin reported that participants undergo several months of IVIG therapy also showed continued improvement in their daily life activities. He added: “These results and the precedents set IVIG is safe to use for the treatment of other diseases, provide a solid foundation for further study in Alzheimer’s patients in a larger scale.”
The association GAP (globulins’s disease) study will examine the safety, efficacy and tolerability of IGIV in patients with mild to moderate renal insufficiency. GAP is recruiting 360 participants in 36 centers nationwide. This large phase III clinical trial expands on previous tests, is one of two phase III trials and is part of the final phase in the study of IVIG as a treatment for AD before seeking regulatory approval.
The trial is responsible for Alzheimer’s Disease Cooperative Study (ADCS), a national consortium of research centers and clinics coordinated by the University of California at San Diego and led by Paul Aisen, MD
“All that five million Americans may be affected, and now with the rapidly increasing number ADCS clinical trials as the study of GAP are essential for finding new and more effective treatments for Alzheimer’s disease,” said Aisen.