The Personalized Parkinson Project (PPP)

NCT03364894 | Active Not Recruiting DMC

• 1 other identifier: NL59694.091.17
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Parkinson's Disease; Biomarkers; Wearable sensors; Imaging; Disease progression

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  From baseline till 2 year follow-up

• Mid-term disease progression in terms of cognitive functioning

  Change in Montreal Cognitive Assessment (MoCA) score

  From baseline till 2 year follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any person with Parkinson's disease who meets the inclusion criteria and does not meet the exclusion criteria.

You may qualify if:

• Subject has Parkinson's disease of ≤5 years duration, defined as time since diagnosis made by a neurologist.
• Subject is an adult, at least 18 years of age.
• Subject can read and understand Dutch.
• Subject has completed the Informed Consent form, as approved by the Ethics Committee.
• Subject is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule and biospecimen collection.
• Subject is not a current employee or family member of employees of the institutions involved in the study.

You may not qualify if:

• Subject is pregnant or breastfeeding.
• Subject is allergic to nickel.
• Subject has co-morbidities that would hamper interpretation of parkinsonian disability, such as coincident musculoskeletal abnormalities, in the opinion of the Investigator.
• Contraindicated for MRI, e.g. claustrophobia, presence of an active implant, pacemaker, insulin pump, neurostimulator, ossicle prosthesis, and/or other medical device or other non-removable metal part incompatible with MRI.
• For lumbar puncture:
• Allergy to local anesthetic agents
• Medical history of compression of spinal cord, current local skin infection at the site of the lumbar puncture, developmental abnormalities in lower spine, blood coagulopathy, anticoagulant medication (Acenocoumarol, Warfarin, Dabigatran).
• Clinical (or previous MRI) evidence of structural cerebral abnormalities that are not compatible with the performance of a lumbar puncture such as malignancies, abscess, or obstructive hydrocephalus.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Verily Life Sciences LLC: collaborator
• University Medical Center Groningen: collaborator
• Maastricht University Medical Center: collaborator
• ParkinsonNet: collaborator
• Dutch Parkinson Patient Association: collaborator
• Topsector Life Sciences and Health: collaborator
• City of Nijmegen (City Hall): collaborator
• Province of Gelderland: collaborator

Study Sites (1)

Radboud university medical center

Nijmegen, 6500 HB, Netherlands

Location

Related Publications (1)

• Bloem BR, Marks WJ Jr, Silva de Lima AL, Kuijf ML, van Laar T, Jacobs BPF, Verbeek MM, Helmich RC, van de Warrenburg BP, Evers LJW, intHout J, van de Zande T, Snyder TM, Kapur R, Meinders MJ. The Personalized Parkinson Project: examining disease progression through broad biomarkers in early Parkinson's disease. BMC Neurol. 2019 Jul 17;19(1):160. doi: 10.1186/s12883-019-1394-3.

  PMID: 31315608 DERIVED

Related Links

• Personalized Parkinson Project study webpage

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimen and stool collection from all enrolled patients and cerebrospinal fluid (CSF) from patients who have provided additional and optional consent to CSF collection, for longitudinal genotypic and phenotypic assays.

MeSH Terms

Conditions

Parkinson Disease; Disease Progression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bastiaan R Bloem, MD, PhD

  Radboud university medical center, department of neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2017
• First Posted: December 7, 2017
• Study Start: October 1, 2017
• Primary Completion: February 15, 2023
• Study Completion (Estimated): March 31, 2028
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Not decided yet.
• Access Criteria: Currently no list of criteria is available.

Locations

NL (1)