ABSTRACT: The Parkinson’s Progression Markers Initiative: A Prospective Biomarkers Study

Parkinson’s disease (PD) interventional trials rely predominantly on clinical outcomes that often vary within subjects and are not consistent across subjects. Reliable and well-validated biomarkers to monitor PD progression would dramatically improve patient care and accelerate research into both PD etiology and therapeutics.  During the past two decades much progress has been made in identifying and assessing PD biomarkers, but as yet, no fully validated biomarker for PD is currently available. Given the recent advances in molecular genetics, neurobiology, imaging technology and radiochemistry that have provided new tools that may be useful for PD biomarkers, and the recognition that the lack of PD progression biomarkers has created a roadblock for further studies of disease modifying therapies, there is increasing consensus that a major initiative to develop PD progression biomarkers is both necessary and feasible. MJFF is planning a large clinical study to enroll 400 PD subjects and 200 healthy controls with the objective to collect clinical, imaging, and biologic data to develop biomarkers of Parkinson’s disease progression. The data will be collected over 3-5 years and will include motor and non-motor clinical data, dopamine scans, and biologic fluid (blood, urine, cerebral spinal fluid) collection. The data will be made available to the PD research community. This initiative will create a consortium of academic centers, government agencies and PD foundations, and pharmaceutical and biotech companies to collectively design, implement and fund a comprehensive program to develop markers of PD progression.  MJFF is currently in the pre-enrollment stage of this study with the goal to launch the study in spring of 2010.