And Potentially Inform Drug Development around Parkinson's Disease Cognitive Decline
The Food and Drug Administration (FDA) plans to make it easier to get novel Alzheimer’s disease (AD) drugs approved for market says The New York Times, news that could also have ramifications for treatments aimed at addressing the cognitive decline that is common to many with Parkinson’s.
According to Times writer Gina Kolata, Alzheimer’s drugs could now be approved if they are shown to help people in clinical trials even before they exhibit some of the more life-altering symptoms of the disease.
Until now, potential AD treatments had to show that they “improved daily, real-world functioning,” which made it difficult to test drugs some thought were better suited for earlier intervention (before activities such as eating, dressing and bathing were impaired). Tests showing this kind of change in behavior in early patients would have had to be very sensitive, and therefore, they were very difficult to devise. But the new FDA proposal suggests drugs could be approved if trial participants merely show subtle improvement in memory and reasoning tests.
The benefits of addressing the disease early on are clear: to stop AD in its tracks, before more advanced symptoms set in, or, as Kolata explains, at the time “when the medications are most likely to be useful (Many scientists agree that once the disease has reached its most advanced stages, where AD drugs have been thus far typically tested in humans, it’s very unlikely that drugs could repair the damage).”
Targeting disease process early is an idea that resonates with the PD community, and in particular, with those researchers beginning to understand the biological mechanisms that lead to cognitive dysfunction in the Parkinson’s brain.
To date, little is known about what causes cognitive impairment in PD (More is known about what might be behind Alzheimer’s). But The Michael J. Fox Foundation (MJFF) is hard at work to learn more about PD cognition, and at that same time, to help construct the most efficient paradigm for getting new drug candidates that target this symptom approved once we have them. To do so, MJFF is working closely with the FDA to define the parameters for measuring whether or not such drugs might work in a clinical setting. It’s here that today’s news could inform these guidelines moving forward.
“The fact that the FDA is willing to accept memory and reasoning tests as outcome measures in Alzheimer’s suggests that they might be willing to accept similar such measures in PD,” says Jamie Eberling, PhD, senior associate director of research programs at MJFF.
In April, MJFF staff, including Eberling and Lona Vincent, associate director of research operations, will meet with the FDA, along with thought leaders in the field of PD cognition, to begin to determine what outcome measures could be used in potential clinical trials moving forward (Last spring, MJFF’s launched a first-of-its-kind collaboration with Sanofi, which marked one of the first ever trials targeting cognitive impairment in PD patients).
“We have a unique opportunity to work directly with the government to define how we measure the effects of drugs that could have a real impact for Parkinson’s patients,” says Eberling.
“The hope is that, in so doing, we can help to streamline the drug development process, and ultimately, get new treatments to the patients that need them, faster.”