$40-million, five-year observational clinical study, sponsored by Michael J. Fox Foundation, will seek biomarkers of Parkinson’s disease
The University of California, San Diego School of Medicine is one of 18 official study sites for the Parkinson’s Progression Markers Initiative (PPMI), a landmark observational clinical study sponsored by The Michael J. Fox Foundation, which will use a combination of advanced imaging, biologics sampling and behavioral assessments to identify biomarkers of Parkinson’s disease (PD) progression. Enrollment of 20 patients and 10 controls is expected to continue for approximately two years.
“PPMI holds potential, not only to accelerate the development of breakthrough Parkinson’s treatments for the future, but also to improve diagnosis and treatment of today’s generation of PD patients,” said Douglas Galasko, MD, professor in the UCSD Department of Neurosciences and the Shiley-Marcos Alzheimer’s Disease Research Center.
Said Michael J. Fox, “This is an ambitious undertaking, no doubt. But nothing worth having comes easily. Everything we’ve learned up to now, the partnerships we’ve worked to forge, the results of research we’ve funded – it’s all put us in position to launch this effort. We’re ready to roll up our sleeves and, hopefully, get this done.”
The lack of a PD biomarker impedes PD diagnosis and treatment, and also critically stalls the development of improved therapies, particularly therapies to slow or stop the progression of PD, something no currently available treatment can do. A biomarker could be any objectively measurable physical characteristic associated with the presence of disease (diagnostic or risk marker), or any characteristic that changes over time in a way that can be tied to the progression of disease (called a progression marker).
Clinical trials of new, potentially disease-modifying Parkinson’s treatments are at risk of yielding inconclusive results, because there is currently no way to measure the effects of those treatments objectively.
“Finding a biomarker is critical to the development of next-generation therapies, and that the lack of this tool is among the most critical issues facing research in Parkinson’s disease,” said Katie Hood, CEO of The Michael J. Fox Foundation. “MJFF has funded biomarker discovery efforts for years. Now we are poised for a concerted, unified effort that will take these discoveries to the next level.”
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About The Parkinson’s Progression Markers Initiative (PPMI)
PPMI, a groundbreaking study to find biomarkers of Parkinson’s disease, will be carried out over five years at 19 clinical sites in the United States and Europe. The study will enroll 400 de novo Parkinson’s patients (patients who are newly diagnosed and have not yet taken PD medication) and 200 healthy age-matched controls. Participants will undergo tests including motor, neuropsychiatric and cognitive examinations; brain imaging with DatSCAN and MRI; and blood, CSF, urine and DNA sampling.
For information on enrolling in PPMI, please contact site coordinator Deborah Fontaine or Christina Gigliotti at 858-622-6301.
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