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A longitudinal program for biomarker development in Parkinson's disease: a feasibility study.
Mov Disord. 2009 Oct 30; 24(14):2081-90.MD

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, alpha-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.

Authors+Show Affiliations

Department of Neurology, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA. bernard.ravina@ctcc.rochester.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

19691116

Citation

Ravina, Bernard, et al. "A Longitudinal Program for Biomarker Development in Parkinson's Disease: a Feasibility Study." Movement Disorders : Official Journal of the Movement Disorder Society, vol. 24, no. 14, 2009, pp. 2081-90.
Ravina B, Tanner C, Dieuliis D, et al. A longitudinal program for biomarker development in Parkinson's disease: a feasibility study. Mov Disord. 2009;24(14):2081-90.
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., & Shoulson, I. (2009). A longitudinal program for biomarker development in Parkinson's disease: a feasibility study. Movement Disorders : Official Journal of the Movement Disorder Society, 24(14), 2081-90. https://doi.org/10.1002/mds.22690
Ravina B, et al. A Longitudinal Program for Biomarker Development in Parkinson's Disease: a Feasibility Study. Mov Disord. 2009 Oct 30;24(14):2081-90. PubMed PMID: 19691116.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A longitudinal program for biomarker development in Parkinson's disease: a feasibility study. AU - Ravina,Bernard, AU - Tanner,Caroline, AU - Dieuliis,Diane, AU - Eberly,Shirley, AU - Flagg,Emily, AU - Galpern,Wendy R, AU - Fahn,Stanley, AU - Goetz,Christopher G, AU - Grate,Stephen, AU - Kurlan,Roger, AU - Lang,Anthony E, AU - Marek,Kenneth, AU - Kieburtz,Karl, AU - Oakes,David, AU - Elliott,Robin, AU - Shoulson,Ira, AU - ,, PY - 2009/8/20/entrez PY - 2009/8/20/pubmed PY - 2010/1/13/medline SP - 2081 EP - 90 JF - Movement disorders : official journal of the Movement Disorder Society JO - Mov Disord VL - 24 IS - 14 N2 - 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, alpha-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. SN - 1531-8257 UR - https://www.unboundmedicine.com/medline/citation/19691116/A_longitudinal_program_for_biomarker_development_in_Parkinson's_disease:_a_feasibility_study_ L2 - https://doi.org/10.1002/mds.22690 DB - PRIME DP - Unbound Medicine ER -