Multi-tasking, focusing attention and remembering can become difficult for some people with Parkinson’s. These symptoms may be a sign of mild cognitive impairment with Parkinson’s disease or PD-MCI. There is no treatment available right now, but The Michael J. Fox Foundation is paving a path to get pharmaceutical companies interested in this part of PD and make approvals from the U.S. Food and Drug Administration (FDA) easier for when a drug is ready.
Two members of our research team with other key opinion leaders recently published a paper outlining the outcomes of their meeting with Parkinson’s research stakeholders and the FDA about PD-MCI. While PD-MCI therapies have made it to clinical trials, none were ever brought to FDA review for market approval. Therefore, there was little instruction for study sponsors.
“With other indications, you know what tests to use, what patient populations to test, what outcome measures the FDA will accept,” said Jamie Eberling, PhD, senior associate director for research programs. “With PD-MCI there is no precedence, so researchers didn’t know what to do.”
That uncertainty is discouraging to pharmaceutical companies. To de-risk the environment, MJFF gathered the FDA, the National Institutes of Health and leading experts in cognition.
One of the most impactful outcomes of that meeting is the understanding that the FDA is open to evaluating PD-MCI drugs measured with different scales. Physicians and researchers use numbered scales (such as Hoehn and Yahr) to measure symptom progression. There is no best practice scale for PD-MCI, but MJFF is working on that, too. In the meantime, drug developers can choose which scale they think is most appropriate for their study population and the drug they’re testing.
Additionally, the FDA wants to see that a PD-MCI drug leads to functional improvement. Rather than relying only on a scale, regulatory officials said they would review quality-of-life measurements as well. In other words, they want to know that people with PD-MCI are living better after taking the drug.
“The FDA will take a patient-centered approach and value the impact on quality of life that a PD-MCI treatment could have, which is good news for the patients and the research field,” said Lona Vincent, an author and senior associate director of research partnerships. “Several companies have expressed interest in pursuing PD-MCI drug development since our meeting.”
Read one person with Parkinson’s take on living with PD-MCI and learn more about what the Foundation is doing in the area of cognition.