A new initiative called the Accelerating Medicines Partnership (AMP) will contribute $129.5 million toward the search for biomarkers and therapeutic targets for Alzheimer’s disease, the National Institutes of Health announced February 4. The goal is to speed up the discovery of treatments in critical and underserved areas of medicine. In addition to funding AD, another $100 million will be spent on Type 2 diabetes and the autoimmune disorders rheumatoid arthritis and lupus, with other diseases to be funded later. About half the money will come from the National Institutes of Health (NIH), and 10 industry partners will donate the rest. Several nonprofit organizations, including the Alzheimer’s Association and USAgainstAlzheimer’s, will help guide the research in collaboration with the Food and Drug Administration. All data and analyses from AMP projects will be made publicly available. The AMP website provides more information, including a list of industry and not-for-profit partners.
For Alzheimer’s disease, the new effort intends to fill two gaps in the present state of the research, said George Vradenburg of USAgainstAlzheimer’s. One is for better biomarkers to track disease in preclinical populations and show if a drug is working. The second is for validated therapeutic targets beyond amyloid and tau. “That will increase the number of shots on goal,” said Vradenburg. Most Alzheimer’s drug candidates have failed in clinical trials, and none have been approved in the last decade. The NIH estimates about a 95 percent failure rate for new drugs for any disorder, and AMP aims to improve this average.
Current AD biomarkers, such as PET amyloid imaging and cerebrospinal fluid (CSF) Aβ and tau, identify people on course to develop the disease, but do not track well with clinical outcomes (see Nov 2012 conference story). Researchers would like to find a surrogate biomarker because that would speed up clinical trials, lower costs, and might allow more drugs to be tested. PET tau tracers, which label neurofibrillary tangles in the brain, show promise in this regard (see Nov 2013 conference story). In addition, some researchers think that electroencephalography (EEG), which directly measures synaptic activity, might reflect cognitive status better than do current biomarkers (see Nov 2012 conference story).
To more fully test these two markers, AMP will fund the addition of PET tau imaging and EEG to three existing prevention trials: the Dominantly Inherited Alzheimer Network trial, the Alzheimer’s Prevention Initiative ApoE4 trial, and the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease (A4) trial. EEG and tau imaging may also be added to a Phase 2 AD study of the approved cancer drug sargramostim. This recombinant granulocyte macrophage colony-stimulating factor pumps up the innate immune system, said Neil Buckholtz, who directs the neuroscience division at the National Institute on Aging. The sargramostim trial received $2.2 million in NIH funding in 2013, and is run by Sanofi Aventis, Cambridge, Massachusetts, one of the AMP partners, in collaboration with scientists at Baylor College of Medicine, Houston. The 24-week trial will test the drug in people with mild cognitive impairment to see if it clears amyloid deposits and slows cognitive decline.
While the biomarker portion of the project will receive the bulk of AMP funding, some money will also support three studies that are searching for new therapeutic targets by developing network models of AD (see Sep 2013 news story). These studies, led by Philip De Jager at Brigham and Women’s Hospital, Boston; David Bennett at Rush University Medical Center, Chicago; Eric Schadt at the Icahn School of Medicine at Mount Sinai, New York; and Todd Golde at the University of Florida, Gainesville, were funded by the NIH in 2013. AMP support will enable the creation of a shared database and help coordinate the efforts of the three groups, Buckholtz said.—Madolyn Bowman Rogers
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