Mild cognitive impairment with Parkinson’s disease (PD-MCI) could be considered the “middle child” between normal cognition and dementia, receiving less attention, at least in the world of drug development. Estimates vary, but some say about 30% of PD patients will experience PD-MCI – gradual decline in the ability to think and reason with subtle difficulties not severe enough to interfere with independence. Insensitive screening instruments and vague diagnostic criteria limit therapies for this level of impairment.
The Michael J. Fox Foundation for Parkinson’s Research (MJFF) is working with the U.S. Food and Drug Administration (FDA) to establish a regulatory pathway for PD-MCI drug development, clinical testing and approval. In April, Lona Vincent, MPH, and Jamie Eberling, PhD, of MJFF and Karl Kieburtz, MD, MPH, of the University of Rochester staff co-chaired “Regulatory Roundtable for Cognitive Impairment in PD.” More than 40 key leaders, including 16 representatives from the FDA, gathered to identify the regulatory requirements for pursuing therapy for PD-MCI.
“Better understanding of who PD-MCI patients are, how to recognize PD-MCI through diagnosis, and how to measure improvement in these patients are critical steps to filling an unmet need so that treatments can be tested in the clinic and ultimately approved by regulatory agencies,” wrote Lona Vincent, MPH, and Jamie Eberling, PhD, in an Outcomes Summary of the Regulatory Roundtable.
Among other outcomes, meeting attendees deemed that existing cognitive scales can be utilized for trials in the short-term, but to better serve patients’ needs, the PD field can develop its own optimal scale for later studies. Following the roundtable, MJFF and the workshop participants have a recommitted interest in filling in the research gaps around PD-MCI diagnosis and outcome measures to move forward along the road to a therapeutic intervention.