Background
Neuroprotection for Parkinson Disease (PD) remains elusive. Biomarkers hold the promise of removing roadblocks to therapy development. The National Institute of Neurological Disorders and Stroke has therefore established the Parkinson’s Disease Biomarkers Program to promote discovery of PD biomarkers for use in phase II-III clinical trials.
Methods
Utilizing a novel consortium design, the Parkinson’s Disease Biomarker Program is focused on the development of clinical and laboratory-based biomarkers for PD diagnosis, progression, and prognosis. Standardized operating procedures and pooled reference samples were created to allow cross-project comparisons and assessment of batch effects. A web-based Data Management Resource facilitates rapid sharing of data and biosamples across the research community for additional biomarker projects.
Results
Eleven consortium projects are ongoing, seven of which recruit participants and obtain biosamples. As of October 2014, 1082 participants have enrolled (620 PD, 101 with other causes of parkinsonism, 23 essential tremor, and 338 controls), 1040 of whom have at least one biosample. There are 6898 total biosamples from baseline, 6, 12, and 18-month visits: 1006 DNA, 1661 RNA, 1419 whole blood, 1382 plasma, 1200 serum, and 230 cerebrospinal fluid (CSF). Quality control analysis of plasma, serum, and CSF samples indicates almost all samples are high quality (24 of 2812 samples exceed acceptable hemoglobin levels).
Conclusions
By making samples and data widely available, using stringent operating procedures based upon existing standards, hypothesis testing for biomarker discovery, and providing a resource which complements existing programs, the Parkinson’s Disease Biomarker Program will accelerate the pace of PD biomarker research.