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. 2019 Jul 17;19(1):160.
doi: 10.1186/s12883-019-1394-3.

The Personalized Parkinson Project: examining disease progression through broad biomarkers in early Parkinson's disease

B R Bloem  1 , W J Marks Jr  2 , A L Silva de Lima  3   4 , M L Kuijf  5 , T van Laar  6 , B P F Jacobs  7 , M M Verbeek  8   9 , R C Helmich  3 , B P van de Warrenburg  3 , L J W Evers  3   10 , J intHout  11 , T van de Zande  12 , T M Snyder  2 , R Kapur  13 , M J Meinders  14
Affiliations

The Personalized Parkinson Project: examining disease progression through broad biomarkers in early Parkinson's disease

B R Bloem et al. BMC Neurol. .

Abstract

Background: Our understanding of the etiology, pathophysiology, phenotypic diversity, and progression of Parkinson's disease has stagnated. Consequently, patients do not receive the best care, leading to unnecessary disability, and to mounting costs for society. The Personalized Parkinson Project (PPP) proposes an unbiased approach to biomarker development with multiple biomarkers measured longitudinally. Our main aims are: (a) to perform a set of hypothesis-driven analyses on the comprehensive dataset, correlating established and novel biomarkers to the rate of disease progression and to treatment response; and (b) to create a widely accessible dataset for discovery of novel biomarkers and new targets for therapeutic interventions in Parkinson's disease.

Methods/design: This is a prospective, longitudinal, single-center cohort study. The cohort will comprise 650 persons with Parkinson's disease. The inclusion criteria are purposely broad: age ≥ 18 years; and disease duration ≤5 years. Participants are followed for 2 years, with three annual assessments at the study center. Outcomes include a clinical assessment (including motor and neuro-psychological tests), collection of biospecimens (stool, whole blood, and cerebrospinal fluid), magnetic resonance imaging (both structural and functional), and ECG recordings (both 12-lead and Holter). Additionally, collection of physiological and environmental data in daily life over 2 years will be enabled through the Verily Study Watch. All data are stored with polymorphic encryptions and pseudonyms, to guarantee the participants' privacy on the one hand, and to enable data sharing on the other. The data and biospecimens will become available for scientists to address Parkinson's disease-related research questions.

Discussion: The PPP has several distinguishing elements: all assessments are done in a single center; inclusion of "real life" subjects; deep and repeated multi-dimensional phenotyping; and continuous monitoring with a wearable device for 2 years. Also, the PPP is powered by privacy and security by design, allowing for data sharing with scientists worldwide respecting participants' privacy. The data are expected to open the way for important new insights, including identification of biomarkers to predict differences in prognosis and treatment response between patients. Our long-term aim is to improve existing treatments, develop new therapeutic approaches, and offer Parkinson's disease patients a more personalized disease management approach.

Trial registration: Clinical Trials NCT03364894 . Registered December 6, 2017 (retrospectively registered).

Keywords: Biomarkers; Cohort studies; Disease progression; Parkinson’s disease; Wearable device.

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Conflict of interest statement

BRB, ALSdL, MLK, TvL, BPFJ, MMV, RCH, BPvdW, LJWE, JiH, TvdZ and MJM declare to have no competing interest.

WJM, TMS and RK are employees of, and equity holder in, Verily Life Sciences LLC.

For the sake of transparency, a full list of disclosures of the first author, Bastiaan R Bloem, is provided: BR Bloem currently serves as Associate Editor for the Journal of Parkinson’s disease, has received honoraria from serving on the scientific advisory board for Zambon and Kyowa Kirin, has received fees for speaking at conferences from AbbVie, Zambon and Bial, and has received research support from the Netherlands Organization for Scientific Research (NWO), the Michael J Fox Foundation for Parkinson’s Research, UCB, the Stichting Parkinson Fonds, the Hersenstichting Nederland, the Parkinson’s Foundation, Verily Life Sciences, Topsector Life Sciences and Health, and the Parkinson Vereniging.

Figures

Fig. 1
Fig. 1
The Verily Study Watch (an Investigational Device), along with syncing/charging cradle and Study Hub. The photographs are owned by Verily and have a copyright. Verily kindly granted written permission to use and adopt if for this publication
See this image and copyright information in PMC

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