FDA Facilitates Research on Earlier Stages of Alzheimer's Disease
A new article from the FDA describes a new approach for the creation of Alzheimer's treatments.
Below is an excert from that article:
"...A recent development could bring better 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 Three years ago, FDA scientists released a draft guidance that may help companies conduct clinical trials focused on what could be a more treatable stage of the disease: before the onset of noticeable dementia.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 Alzheimer’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 A 2013 FDA draft guidance responded to this development by discussing the design of clinical trials for drugs for Alzheimer’s patients who are still in the very early stages of the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.
FDA’s draft guidance may help researchers design clinical trials for early stage Alzheimer’s therapies. The agency hopes that the guidance will serve as a focus for continued discussions among FDA, sponsors of new drugs, the academic community, and the public."
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