The FDA may relax the guidelines on Alzheimer’s early stage trials in an effort to speed up the development of new treatments. The FDA has issued a proposal designed to help researchers create new treatments before the onset of noticeable dementia.
Early stage Alzheimer’s lacks definitive biological markers making it virtually impossible to enroll patients in experimental drug trials for this stage of the disease. This makes it extremely difficult to create new treatments during the time when they could very likely be most effective.
“The scientific community and the FDA believe that it is critical to identify and study patients with very early Alzheimer’s disease before there is too much irreversible injury to the brain,” said Russell Katz, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “It is in this population that most researchers believe that new drugs have the best chance of providing meaningful benefit to patients.”
Detecting Alzheimer's in patients
During the last few years, researchers have tried to find ways of using biomarkers to detect Alzheimer’s in the very early stages. A biomarker can be a molecule, gene or some characteristic that helps doctors diagnose a disease or a risk of developing a disease.
Doctors are now better able to predict Alzheimer’s by using a combination of brain imaging and biomarker tests. Still, doctors can more accurately predict Alzheimer’s by measuring people’s cognitive abilities. The new draft outline includes observation as well as quantitative measurements to qualify a person to join a study.
FDA willing to be more flexible in determining success
Since there is usually no global functioning impairment at the early stages of the disease, an experimental drug would need to show only a slow down of mental decline. It would not be necessary, for instance, to show improved self-care since that is not an issue. As a result, more drugs could be approved more quickly.
Source: FDA, MedicalNewsToday
Photo: Auguste Deter. Alois Alzheimer's patient in November 1901, first described patient with Alzheimer's Disease.