An observational study in Parkinson Disease, sponsored by Radboud University Medical Center. Active, not recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-24.
Sponsored by Radboud University Medical Center · Observational
Background Our understanding of PD has stagnated, partly due to the limited patient diversity and brief followup captured in most study cohorts. Additionally, potentially valuable biomarkers derived from different types of measurements are rarely analyzed in an integrated fashion.
Objective This study aims to create a longitudinal dataset of clinical, molecular, imaging, and continuous wearable sensor-based data from a representative Parkinson's disease (PD) cohort. Data will be made available to researchers worldwide to accelerate the discovery of novel etiological insights, development of new therapeutic approaches, and personalized disease management. For this purpose, an extensible norm for sharing research data will be developed, meeting the latest data privacy and security standards.
Methods Supported by a multinational, public-private partnership, a prospective cohort study was designed to include 650 representative PD patients (disease duration \<5 years). Comprehensive follow-up for at least 2 years includes: (1) annual assessment at the study center for acquisition of detailed clinimetric data, magnetic resonance imaging, and biospecimens (plasma, serum, cerebrospinal fluid (CSF), stool) and (2) collection of data from the home environment, using self-assessments and an advanced wrist-worn wearable device to continuously measure biological and environmental signals. Collection, storage, and sharing of these research data will be facilitated by a new method to protect privacy and enhance security using polymorphic encryption and pseudonymization (PEP), a methodology that combines advanced encryption with distributed pseudonymization and data access management.
Conclusion This study is unique, as it includes a cohort of unbiased subjects with recently diagnosed PD, creating an unprecedented dataset that combines longitudinally collected clinical, molecular, imaging, and data from wearable sensors using state of the art technology. The single-center study design minimizes measurement variability. Finally, the innovative methodology for data privacy and protection might serve as a new international standard for sharing research data.
The Personalized Parkinson Project proposes an unbiased approach to biomarker development with multiple clinical, genomic and other molecular, and imaging biomarkers measured in a large population, measured at 3 time points (baseline visit, one year follow-up, and two years' follow-up). In addition, the study protocol includes day-to-day patient monitoring with a multisensor wearable device, the Verily Study Watch, that continuously collects data (movement, pulse, skin temperature, ambient information) and allows for real-time data collection between study visits. The goal of the device is to collect high-resolution, continuous biological signals from the body. These measurements of physiology, activity, and environmental conditions over the course of a 2-year study will be used to create a quantified functional assessment of patients with PD. Mapping these signals with clinical outcomes such as disease progression will allow the investigators to evaluate the relationship between biosensor data and the clinical variables, genotypic, and imaging biomarkers collected in the study.
This study is intended to create a unique resource of genotypic, functional, and phenotypic data collected longitudinally on a cohort of Dutch subjects with PD (n=650), allowing the Research Collaborators to address a series of hypothesis-driven research questions. The aim is to develop novel etiological insights, to identify biomarkers that can assist in predicting differences in prognosis and treatment response between patients, to improve existing treatments, to develop new therapeutic approaches, and to develop a more precise and personalized disease management approach.
Additionally, the cohort will serve as a source of data that can be accessed by qualified researchers worldwide, allowing them to add their research capacity to further address the main aims of this study. For this reason, data governance will be managed by dedicated advisory boards and data review committees, as specified in the study protocol. Participation in this study and results from this study will not be used for patient treatment decisions.
The aim of this study is threefold:
Any person with Parkinson's disease who meets the inclusion criteria and does not meet the exclusion criteria.
Exclusion Criteria:
For lumbar puncture:
Short-term disease progression in terms of motor symptoms
Change in Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score, measured in off state. This scale assesses 18 motor symptoms (33 items) that are specific for Parkinson's disease. Item scores range from 0 to 4 and are summed, resulting in a total score ranging from 0 to 132, with higher scores representing worse outcomes.
Time frame: From baseline till 1 year follow-up
Short-term disease progression in terms of cognitive functioning
Change in Montreal Cognitive Assessment (MoCA) score. The MoCa assesses in 30 items different types of cognitive abilities (0-1 scale), including orientation, short-term memory and attention. All items are summed, resulting in a total score ranging from 0 to 30, with higher scores representing better outcomes.
Time frame: From baseline till 1 year follow-up
Mid-term disease progression in terms of motor symptoms
Change in MDS-UPDRS part III score, measured in off state.
Time frame: From baseline till 2 year follow-up
Mid-term disease progression in terms of cognitive functioning
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: From baseline till 2 year follow-up
Plan to share: Yes — The dataset generated in this study will become available to qualified researchers worldwide, provided research questions are approved by the Research and Data Sharing Review Committee (RDSRC). The RDSRC will protect subjects' privacy by limiting the availability of the study data and controlling access to sources of information that might potentially be used to identify the individual subjects associated with the biospecimen analysis. The RDSRC will assess the relevance and scientific quality of research proposals for which study data or material is requested. These responsibilities include the consideration of applications for: * access to the resources obtained in this study, including data or biomaterials * applications for endorsement of a scientific project using study materials; * applications for endorsement of a clinical study using study materials.
Supporting information: Study protocol
This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Radboud University Medical Center