This week the FDA announced a new element in Alzheimer’s research that may help unlock some of the mysteries about the disease. The organization has issued a proposal designed to help companies that develop Alzheimer’s treatments. Specifically, they are wanting to assist those companies who target patients for clinical trials as they develop new medications.
Within “Guidance for Industry, Alzheimer’s Disease: Developing Drugs for the Treatment of Early Stage Disease,” they explain what the FDA is thinking in terms of how to best select patients for trials, as they are now hoping to focus on those who are in the very early stages or even in the at-risk category.
Dr. Russell Katz, M.D. is the director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. He provided a statement in the FDA press release about this new process of evaluation.
“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. It is in this population that most researchers believe that new drugs have the best chance of providing meaningful benefit to patients,” said Dr. Katz.
DietsInReview.com resident pharmacist, Dr. Sarah G. Khan, helped us understand some of the hurdles this new direction will provide for the FDA. Khan explained how the goal is understandable, yet executing it will be the struggle as the early stages of Alzheimer’s is so hard to diagnose. This would make it very hard to find the right patients. Furthermore, Khan explained how the marked measurement of improvement will also be difficult in early-staged patients due to no impairment of functioning to monitor.
Even with the hurdles, it’s exciting to see a major shift in research for this terrible disease. Hopefully the new direction will lead to major developments in treatments and the hopefully cure for Alzheimer’s.
Alzheimer’s disease is an irreversible, progressive brain disease that slowly destroys memory and thinking skills, and eventually the ability to carry out the simplest tasks of daily living. In most people with Alzheimer’s, symptoms first appear after age 60. Alzheimer’s disease is the most common cause of dementia among older people.