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  • Study protocol of the DUtch...
    Boertien, Jeffrey M.; van der Zee, Sygrid; Chrysou, Asterios; Gerritsen, Marleen J. J.; Jansonius, Nomdo M.; Spikman, Jacoba M.; van Laar, Teus; Verwey, N. A.; Van Harten, B.; Portman, A. T.; Langedijk, M. J. H.; Oomes, P. G.; Jansen, B. J. A. M.; Van Wieren, T.; Van den Bogaard, S. J. A.; Van Steenbergen, W.; Duyff, R.; Van Amerongen, J. P.; Fransen, P. S. S.; Polman, S. K. L.; Zwartbol, R. T.; Van Kesteren, M. E.; Braakhekke, J. P.; Trip, J.; Koops, L.; De Langen, C. J.; De Jong, G.; Hartono, J. E. S.; Ybema, H.; Bartels, A. L.; Reesink, F. E.; Postma, A. G.; Vonk, G. J. H.; Oen, J. M. T. H.; Brinkman, M. J.; Mondria, T.; Holscher, R. S.; Van der Meulen, A. A. E.; Rutgers, A. W. F.; Boekestein, W. A.; Teune, L. K.; Orsel, P. J. L.; Hoogendijk, J. E.; Van Laar, T.

    BMC neurology, 06/2020, Volume: 20, Issue: 1
    Journal Article

    Abstract Background Parkinson’s Disease (PD) is a heterogeneous, progressive neurodegenerative disorder which is characterized by a variety of motor and non-motor symptoms. To date, no disease modifying treatment for PD exists. Here, the study protocol of the Dutch Parkinson Cohort (DUPARC) is described. DUPARC is a longitudinal cohort study aimed at deeply phenotyping de novo PD patients who are treatment-naïve at baseline, to discover and validate biomarkers for PD progression, subtypes and pathophysiology. Methods/design DUPARC is a prospective cohort study in which 150 de novo PD subjects will be recruited through a collaborative network of PD treating neurologists in the northern part of the Netherlands (Parkinson Platform Northern Netherlands, PPNN). Participants will receive follow-up assessments after 1 year and 3 years, with the intention of an extended follow-up with 3 year intervals. Subjects are extensively characterized to primarily assess objectives within three major domains of PD: cognition, gastrointestinal function and vision. This includes brain magnetic resonance imaging (MRI); brain cholinergic PET-imaging with fluoroethoxybenzovesamicol (FEOBV-PET); brain dopaminergic PET-imaging with fluorodopa (FDOPA-PET); detailed neuropsychological assessments, covering all cognitive domains; gut microbiome composition; intestinal wall permeability; optical coherence tomography (OCT); genotyping; motor and non-motor symptoms; overall clinical status and lifestyle factors, including a dietary assessment; storage of blood and feces for additional analyses of inflammation and metabolic parameters. Since the start of the inclusion, at the end of 2017, over 100 PD subjects with a confirmed dopaminergic deficit on FDOPA-PET have been included. Discussion DUPARC is the first study to combine data within, but not limited to, the non-motor domains of cognition, gastrointestinal function and vision in PD subjects over time. As a de novo PD cohort, with treatment naïve subjects at baseline, DUPARC provides a unique opportunity for biomarker discovery and validation without the possible confounding influences of dopaminergic medication. Trial registration NCT04180865 ; registered retrospectively, November 28th 2019.