NCT03364894: PPP

The Personalized Parkinson Project (PPP)

Active, enrolled Last updated 24 March 2025

What this trial tests

trial in Parkinson Disease in 520 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 October 2017

Primary endpoint
15 February 2023

31 March 2028

Quick facts

Lead sponsor	Radboud University Medical Center
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	520
Start date	1 October 2017
Primary completion	15 February 2023
Estimated completion	31 March 2028
Sites	1 location across Netherlands

Conditions studied

• Parkinson Disease — all drugs for Parkinson Disease →

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Parkinson Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Personalized Parkinson Project: examining disease progression through broad biomarkers in early Parkinson's disease.
   Bloem BR, Marks WJ, Silva de Lima AL, Kuijf ML, et al · · 2019 · cited 86× · PMID 31315608 · DOI 10.1186/s12883-019-1394-3
2. Clinical severity in Parkinson's disease is determined by decline in cortical compensation.
   Johansson ME, Toni I, Kessels RPC, Bloem BR, et al · · 2024 · cited 51× · PMID 37757883 · DOI 10.1093/brain/awad325
3. Two-year clinical progression in focal and diffuse subtypes of Parkinson's disease.
   Johansson ME, van Lier NM, Kessels RPC, Bloem BR, et al · · 2023 · cited 27× · PMID 36806285 · DOI 10.1038/s41531-023-00466-4
4. Predictors of stress resilience in Parkinson's disease and associations with symptom progression.
   van der Heide A, Dommershuijsen LJ, Puhlmann LMC, Kalisch R, et al · · 2024 · cited 13× · PMID 38605033 · DOI 10.1038/s41531-024-00692-4
5. Parkinson's disease progression is shaped by longitudinal changes in cerebral compensation.
   Johansson ME, Toni I, Bloem BR, Helmich RC. · · 2026 · cited 2× · PMID 40796318 · DOI 10.1093/brain/awaf302
6. Optimizing wrist-worn wearable compliance with insights from two Parkinson's disease cohort studies.
   Meinders MJ, Heathers L, Ho KC, Russell L, et al · · 2025 · cited 2× · PMID 40480983 · DOI 10.1038/s41531-025-01016-w
7. The interplay between stress, inflammation and Parkinson's disease: insights from the COVID-19 pandemic.
   van der Heide A, Kischkel B, Rovers CP, de Jonge MI, et al · · 2025 · cited 1× · PMID 41271761 · DOI 10.1038/s41531-025-01178-7
8. Heart rate monitoring using wrist photoplethysmography in Parkinson disease: feasibility and relation with autonomic dysfunction
   Veldkamp KI, Evers LJ, van Laarhoven T, Raykov YP, et al · · 2025 · DOI 10.1101/2025.08.15.25333751