title: The NINDS Parkinson's disease biomarkers program.
abstract: Neuroprotection for Parkinson's 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 and III clinical trials.
  
  
  
  Using 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.
  
  
  
  Eleven consortium projects are ongoing, seven of which recruit participants and obtain biosamples. As of October 2014, 1,082 participants have enrolled (620 PD, 101 with other causes of parkinsonism, 23 essential tremor, and 338 controls), 1,040 of whom have at least one biosample. Six thousand eight hundred ninety-eight total biosamples are available from baseline, 6-, 12-, and 18-month visits: 1,006 DNA, 1,661 RNA, 1,419 whole blood, 1,382 plasma, 1,200 serum, and 230 cerebrospinal fluid (CSF). Quality control analysis of plasma, serum, and CSF samples indicates that almost all samples are high quality (24 of 2,812 samples exceed acceptable hemoglobin levels).
  
  
  
  By making samples and data widely available, using stringent operating procedures based on existing standards, hypothesis testing for biomarker discovery, and providing a resource that complements existing programs, the Parkinson's Disease Biomarker Program will accelerate the pace of PD biomarker research. © 2015 International Parkinson and Movement Disorder Society.
authors.affiliation: Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Liana S
authors.initials: LS
authors.lastname: Rosenthal
authors.affiliation: Department of Biostatistics, Columbia University, New York, New York, USA.
authors.forename: Daniel
authors.initials: D
authors.lastname: Drake
authors.affiliation: Department of Neurology, Columbia University, New York, New York, USA.
authors.forename: Roy N
authors.initials: RN
authors.lastname: Alcalay
authors.affiliation: National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Debra
authors.initials: D
authors.lastname: Babcock
authors.affiliation: Department of Biostatistics, Columbia University, New York, New York, USA.
authors.forename: F DuBois
authors.initials: FD
authors.lastname: Bowman
authors.affiliation: Department of Neurology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
authors.forename: Alice
authors.initials: A
authors.lastname: Chen-Plotkin
authors.affiliation: Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.|Neuroregeneration and Stem Cell Programs, Institute for Cell Engineering, Solomon H. Snyder Department of Neuroscience, Pharmacology and Molecular Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
authors.forename: Ted M
authors.initials: TM
authors.lastname: Dawson
authors.affiliation: Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, USA.
authors.forename: Richard B
authors.initials: RB
authors.lastname: Dewey
authors.affiliation: Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, USA.
authors.forename: Dwight C
authors.initials: DC
authors.lastname: German
authors.affiliation: Department of Neurology, Penn State Hershey Medical Center, Hershey, Pennsylvania, USA.
authors.forename: Xuemei
authors.initials: X
authors.lastname: Huang
authors.affiliation: Center for Information Technology, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Barry
authors.initials: B
authors.lastname: Landin
authors.affiliation: Center for Information Technology, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: McAuliffe
authors.affiliation: Biological Sciences Division, Pacific Northwest National Laboratory, Richland, Washington, USA.
authors.forename: Vladislav A
authors.initials: VA
authors.lastname: Petyuk
authors.affiliation: Department of Neurology, Brigham & Women's Hospital, Harvard Medical School, Cambridge, Massachusetts, USA.
authors.forename: Clemens R
authors.initials: CR
authors.lastname: Scherzer
authors.affiliation: National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Coryse St
authors.initials: CS
authors.lastname: Hillaire-Clarke
authors.affiliation: National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Beth-Anne
authors.initials: BA
authors.lastname: Sieber
authors.affiliation: National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Margaret
authors.initials: M
authors.lastname: Sutherland
authors.affiliation: Coriell Institute for Medical Research, Camden, New Jersey, USA.
authors.forename: Chi
authors.initials: C
authors.lastname: Tarn
authors.affiliation: Department of Neurology, University of Alabama at Birmingham, Birmingham, USA.
authors.forename: Andrew
authors.initials: A
authors.lastname: West
authors.affiliation: Department of Applied Physiology and Kinesiology, University of Florida, Gainesville, Florida, USA.
authors.forename: David
authors.initials: D
authors.lastname: Vaillancourt
authors.affiliation: Department of Pathology, University of Washington, Seattle, Washington, USA.
authors.forename: Jing
authors.initials: J
authors.lastname: Zhang
authors.affiliation: National Institute of Neurological Diseases and Stroke, National Institutes of Health, Bethesda, Maryland, USA.
authors.forename: Katrina
authors.initials: K
authors.lastname: Gwinn
mesh_terms: D015415:Biomarkers; D006801:Humans; D015337:Multicenter Studies as Topic; D055825:National Institute of Neurological Disorders and Stroke (U.S.); D010300:Parkinson Disease / Q000175:diagnosis*; D016730:Program Development; D014481:United States
chemical_list: D015415:Biomarkers
keywords: Parkinsonism; biofluids; data management; disease-modifying strategies