Research Article

A longitudinal program for biomarker development in Parkinson's disease: A feasibility study†

  1. Bernard Ravina MD, MSCE1,*,
  2. Caroline Tanner MD, PhD2,
  3. Diane DiEuliis PhD3,
  4. Shirley Eberly MS1,
  5. Emily Flagg BA1,
  6. Wendy R. Galpern MD, PhD3,
  7. Stanley Fahn MD4,
  8. Christopher G. Goetz MD5,
  9. Stephen Grate DVM6,
  10. Roger Kurlan MD1,
  11. Anthony E. Lang MD7,
  12. Kenneth Marek MD8,
  13. Karl Kieburtz MD, MPH1,
  14. David Oakes PhD1,
  15. Robin Elliott MA9,
  16. Ira Shoulson MD1

Article first published online: 18 AUG 2009

DOI: 10.1002/mds.22690

Issue

Movement Disorders

Movement Disorders

Volume 24, Issue 14, pages 2081–2090, 30 October 2009

Additional Information

How to Cite

Ravina, B., Tanner, C., DiEuliis, D., Eberly, S., Flagg, E., Galpern, W. R., Fahn, S., Goetz, C. G., Grate, S., Kurlan, R., Lang, A. E., Marek, K., Kieburtz, K., Oakes, D., Elliott, R. and Shoulson, I. (2009), A longitudinal program for biomarker development in Parkinson's disease: A feasibility study. Mov. Disord., 24: 2081–2090. doi: 10.1002/mds.22690

Author Information

  1. 1

    Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA

  2. 2

    The Parkinson's Institute, Sunnyvale, California, USA

  3. 3

    The National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Maryland, USA

  4. 4

    Department of Neurology, Columbia University, New York, New York, USA

  5. 5

    Department of Neurosciences, Rush University Medical Center, Chicago, Illinois, USA

  6. 6

    Telemedicine and Advanced Technology Research Center, Fort Detrick, Maryland, USA

  7. 7

    Department of Medicine, Division of Neurology, Univerisity of Toronto, Toronto, Ontario, Canada

  8. 8

    Institute for Neurodegenerative Disorders, New Haven, Connecticut, USA

  9. 9

    The Parkinson's Disease Foundation, New York, New York, USA

*1351 Mt. Hope Ave., Suite 223, Rochester, NY 14620

  1. †

    Potential conflict of interest: None reported.

Publication History

  1. Issue published online: 28 OCT 2009
  2. Article first published online: 18 AUG 2009
  3. Manuscript Accepted: 10 JUN 2009
  4. Manuscript Received: 22 APR 2009

Funded by

  • National Institute of Neurological Disorders and Stroke. Grant Number: 5U01NS050095-05
  • Department of Defense Neurotoxin Exposure Treatment Parkinson's Research Program. Grant Number: W23RRYX7022N606
  • Michael J Fox Foundation
  • Parkinson's Disease Foundation
  • Lundbeck Pharmaceuticals
  • Cephalon Inc
  • Lundbeck Inc
  • John Blume Foundation
  • Smart Family Foundation
  • RJG Foundation
  • Kinetics Foundation
  • National Parkinson Foundation
  • Amarin Neuroscience LTD
  • CHDI Foundation Inc
  • National Institutes of Health (NHGRI, NINDS)
  • Columbia Parkinson's Disease Research Center

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Keywords:

  • Parkinson's disease;
  • progression;
  • biomarker

Abstract

Long-term follow up is necessary to understand the natural history of treated Parkinson's disease (PD). The Longitudinal and Biomarker Study in PD (LABS-PD) is an observational study designed to prospectively measure the evolution of motor and non-motor features of PD and sample promising biomarkers from early to late stage illness. LABS-PD is organized on the premise that cohorts from completed clinical trials can be re-recruited for long-term follow up. LABS-PD will eventually contain multiple cohorts, but to test the feasibility of the strategy, we examined enrollment and biomarker sampling in the initial cohorts. The first PD cohort (PostCEPT) comes from the de novo clinical trial of a mixed lineage kinase inhibitor (PRECEPT). We assessed the recruitment from PRECEPT to PostCEPT, the ability to link data from the two studies, and sample collection for a variety of biomarkers. A total of 537 of 709 eligible PRECEPT subjects (76%) enrolled in PostCEPT; 509 (95%) had repeat dopamine transporter imaging. PRECEPT clinical and imaging data were successfully linked to PostCEPT, to provide 3 to 4 year follow-up. A biomarker sub-study enrolled over 100 PD cases from PostCEPT and 100 controls to measure olfaction and blood markers of gene expression, α-synuclein, and proteomic profiles. We were also successful in linking clinical and biomarker data to DNA samples that have been collected in the publicly accessible Coriell repository. The PostCEPT cohort and associated studies strongly support the feasibility of the LABS-PD approach of retaining and repurposing clinical trial cohorts to collect longitudinal clinical and biomarker data. © 2009 Movement Disorder Society

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