FDA Proposes Draft to Allow Alzheimer Drug Testing During Early Stages
A new plan by the U.S. Food and Drug Administration (FDA) announced on Thursday will allow drug companies to test out their products on Alzheimer's patients who are still in early stages, which is when researchers believe the drugs stand a better chance of being more 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 Dr. Russell Katz, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research.
The Alzheimer's drugs that are currently available treat symptoms, but none have been effective in preventing patients to lose their memories.
"I think this will be hugely useful to the pharmaceutical industry," said Dr. Paul Aisen of the University of California, San Diego, and director of the Alzheimer's Disease Cooperative Study, a joint effort between the university and the National Institute on Aging focused on identifying the earliest signs of Alzheimer's.
There is a growing need for an Alzheimer's cure as a new study released Wednesday estimate that the number of Americans with Alzheimer's disease is set to triple to 13.8 million by 2050.
According to Reuters, researchers now plan to study Lilly's drug in patients with earlier-stage disease, including a trial known as the "A4" prevention study, which will study 1,000 volunteers aged 70 to 85 with pre-symptomatic disease, who have not yet developed significant memory problems.
Click here to read the complete draft by the FDA.