A landmark paper published in The Lancet Neurology journal by leaders of the Parkinson’s Progression Markers Initiative (PPMI), the gold-standard Parkinson’s biomarker study sponsored by The Michael J. Fox Foundation for Parkinson’s Research (MJFF), confirms the most significant breakthrough yet in the search for a Parkinson’s biomarker: a biological test for Parkinson’s disease that demonstrates high diagnostic accuracy, differentiates molecular subtypes and detects disease in individuals before cardinal movement symptoms arise.
The new test, known as the alpha-synuclein seed amplification assay (αSyn-SAA), heralds the revolutionary ability for research to define Parkinson’s disease biologically, offering a critical tool for clinical trial design and assessment of treatment effects, and for early detection of disease pathology.
As authors from PPMI detail in The Lancet Neurology, the test detects synuclein pathology, one of the two biological hallmarks of Parkinson’s disease. As a result, for the first time since James Parkinson first characterized the disorder in 1817, researchers and clinicians can use biology to identify, define and monitor Parkinson’s objectively, based on cellular pathology in the living body.
“Validation of this biomarker launches a new, biological era in Parkinson’s research,” said Kenneth Marek, MD, PPMI Principal Investigator and president and senior scientist at the Institute for Neurodegenerative Disorders. “Using αSyn-SAA, we are already unlocking new understanding of Parkinson’s, which will transform every aspect of drug development and ultimately clinical care. We will rapidly be in a position to test new therapies in the right populations, target the right therapy to the right patient at the right time, and launch studies of agents with potential to prevent Parkinson’s disease altogether. This is what PPMI was built to do, and we are especially grateful to the thousands of study participants whose contributions have enabled this watershed moment.”
The paper, co-led by Andrew Siderowf, MD, PPMI Investigator and Director, Parkinson Disease and Movement Disorders Center at the University of Pennsylvania and Luis Concha, PhD, Director, Research and Development at Amprion, outlines αSyn-SAA results from more than 1,100 PPMI participants including individuals with Parkinson’s disease, those with genetic and/or clinical risk factors but not diagnosed with Parkinson’s, and control volunteers.
SOURCE: PR Newswire