The Michael J. Fox Foundation has launched what it claims is the first large-scale clinical study focused on identifying and validating biomarkers of Parkinson disease (PD) progression. The five-year, $40 million Parkinson’s Progression Markers Initiative (PPMI) will take the form of an observational study, monitoring 400 patients with newly diagnosed PD and 200 healthy controls. Carried out at 18 sites in the U.S. and Europe, patient recruitment is under way at six sites, and all participating establishments are expected to be recruiting by the end of 2010, the foundation states.
Through the analysis of biological samples and clinical data the project aims to establish a scientific model for testing potential PD biomarkers, and accelerating biomarker discovery, validation, and clinical testing. PPMI will operate an open-source research model to make resulting data and clinical samples available to qualified researchers outside the study.
“With PD progression biomarkers in hand, it will be possible to establish objective endpoints for clinical trials of disease-modifying Parkinson’s treatments,” notes Kenneth L. Marek, M.D., PPMI principal investigator and senior scientist at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. “Endpoints are concrete ways to demonstrate that a candidate therapy is, or is not, slowing disease course in PD patients, as opposed to simply treating disease symptoms. Without a biomarker, this sort of evidence-based decision-making is much more difficult.”