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MEMORY CARE


FDA Facilitates Research on Earlier Stages of Alzheimer’s Disease


A


lzheimer’s disease is a nightmare haunting many Americans. More than 5 million Americans


have been diagnosed with the disease, which is the sixth leading cause of death in the United States and the most common cause of dementia among people 60 or older. Alz- heimer’s is an irreversible, progressive brain disease that slowly destroys memory and thinking skills. It eventually robs sufferers of the ability to perform even the simplest tasks of daily life. Despite years of intensive efforts by sci-


entists to develop new safe and effective treatments for Alzheimer’s, options remain limited. In the last 20 years, FDA has ap- proved five drugs for the disease—the most recent one in 2003. Although the drugs can provide some benefit, more needs to be done. A recent development could bring bet-


ter results. Three years ago, FDA scientists released a draft guidance that may help companies conduct clinical trials focused on what could be a more treatable stage of the disease: before the onset of noticeable dementia. Research has shown that there is a lag


of many years between the beginning of changes in a patient’s brain and the onset of Alzheimer’s symptoms. Yet in the past, clinical trials examined Alzheimer’s patients when their symptoms had become clearly apparent, long after the changes in their brains had started. Some researchers have theorized that the greatest benefits will be available if a treatment can be developed for very early in the disease course, when people have the very first symptoms of Alz- heimer’s—or even earlier. For that reason, the development of drugs


for the treatment of Alzheimer’s disease has increasingly focused on the stages before the onset of overt dementia. A 2013 FDA draft guidance responded to this development


by discussing the design of clinical trials for drugs for Alzheimer’s patients who are still in the very early stages of the disease, when only subtle symptoms are present. “There may be a window of opportunity


to affect the disease before people experi- ence symptoms,” says Eric Bastings, M.D., a neurologist and the deputy director of FDA’s Division of Neurology Products. FDA’s draft guidance may help research-


ers design clinical trials for early stage Alz- heimer’s therapies. The agency hopes that the guidance will serve as a focus for con- tinued discussions among FDA, sponsors of new drugs, the academic community, and the public. “Earlier and more precise identification


of patients with early changes in the brain who will go on to develop Alzheimer’s is important for the success of these clinical studies,” says Billy Dunn, M.D., a neurol- ogist and the director of FDA’s Division of


52 SENIOR LIVING EXECUTIVE / NOVEMBER/DECEMBER 2016


Neurology Products. “We hope that earlier interventions, before further extensive dam- age to the brain sets in, will be more success- ful. We’re very excited about the potential for this research to result in safe and effective treatments for early Alzheimer’s disease.”


New Paths for New Alzheimer’s Drugs FDA’s draft guidance aims to encour-


age research and discusses FDA’s thinking about conducting new clinical trials at the very early stages of Alzheimer’s disease—in patients with no obvious symptoms, or even no symptoms at all. One example of how clinical trials are


changing is the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study, a land- mark public-private partnership funded in part by the National Institute on Aging. Participants are people ages 65 to 85 who have normal thinking and memory function Continued on page 54


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