Parkinson DiseasePPPNCT03364894
The Personalized Parkinson Project (PPP)
An observational study of Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- How many people
- 520 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Oct 2017to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any person with Parkinson's disease who meets the inclusion criteria and does not meet the exclusion criteria.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Personalized Parkinson Project (De Parkinson Op Maat Studie)
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.
Read more
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.
Read the detailed description
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:
- The primary objective of the study is to perform a set of hypothesis-driven analyses on the study data set, aiming to correlate established biomarkers (obtained clinically, from brain magnetic resonance imaging (MRI), from cerebrospinal fluid (CSF), from known genetic factors, and from monitoring of biosensors signals) to the rate of disease progression, and to responses to treatment (both pharmacological and behavioral, such as participation in exercise). Also, the investigators aim to identify biomarkers that can assist in predicting differences in prognosis and treatment response between patients. Finally, by developing novel etiological and pathophysiological insights, the study aims to improve existing treatments and to develop new therapeutic approaches, as a basis for development of a more precise and personalized disease management approach.
- The secondary objective of the study is to evaluate the Verily Study Watch, to assess how these devices could provide information about the function of patients with PD.
- The tertiary objective of this study is to create an extensive longitudinal dataset describing the genetic, clinical, functional, and phenotypic characteristics of a representative Parkinson's disease (PD) subject cohort (n = 650) to allow researchers to investigate important unanswered questions in PD.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Biomarkers, Wearable sensors, Imaging, Disease progression
- Medical subject headings
- Parkinson Disease, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From baseline till 2 year follow-up
Mid-term disease progression in terms of cognitive functioning
Change in Montreal Cognitive Assessment (MoCA) score
Measured: From baseline till 2 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Oct 2017
- Primary completion15 Feb 2023
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 520 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Verily Life Sciences LLC, University Medical Center Groningen, Maastricht University Medical Center, ParkinsonNet, Dutch Parkinson Patient Association, Topsector Life Sciences and Health, City of Nijmegen (City Hall), Province of Gelderland
- Responsible party
- Sponsor
- Investigators
- Bastiaan R Bloem, MD, PhD, Principal investigator, Radboud university medical center, department of neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364894
- Sponsor's protocol ID
- NL59694.091.17
- Acronym
- PPP
- Status last verified
- Mar 2025
- First submitted
- 23 Nov 2017
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Heye K, Li R, Bai Q, St George RJ, Rudd K, Huang G, Meinders MJ, Bloem BR, Alty JE. Validation of computer vision technology for analyzing bradykinesia in outpatient clinic videos of people with Parkinson's disease. J Neurol Sci. 2024 Nov 15;466:123271. doi: 10.1016/j.jns.2024.123271. Epub 2024 Oct 15.
PubMed 39476714Bloem 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.
PubMed 31315608
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Personalized Parkinson Project (De Parkinson Op Maat Studie)
- ClinicalTrials.gov ID
- NCT03364894
- Acronym / sponsor ID
- PPP / NL59694.091.17
- Conditions
- Parkinson Disease
- Keywords
- Parkinson's Disease, Biomarkers, Wearable sensors, Imaging, Disease progression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 520 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Verily Life Sciences LLC, University Medical Center Groningen, Maastricht University Medical Center, ParkinsonNet, Dutch Parkinson Patient Association, Topsector Life Sciences and Health, City of Nijmegen (City Hall), Province of Gelderland
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- The primary objective of the study is to perform a set of hypothesis-driven analyses on the study data set, aiming to correlate established biomarkers (obtained clinically, from brain magnetic resonance imaging (MRI), from cerebrospinal fluid (CSF), from known genetic factors, and from monitoring of biosensors signals) to the rate of disease progression, and to responses to treatment (both pharmacological and behavioral, such as participation in exercise). Also, the investigators aim to identify biomarkers that can assist in predicting differences in prognosis and treatment response between patients. Finally, by developing novel etiological and pathophysiological insights, the study aims to improve existing treatments and to develop new therapeutic approaches, as a basis for development of a more precise and personalized disease management approach.
- The secondary objective of the study is to evaluate the Verily Study Watch, to assess how these devices could provide information about the function of patients with PD.
- The tertiary objective of this study is to create an extensive longitudinal dataset describing the genetic, clinical, functional, and phenotypic characteristics of a representative Parkinson's disease (PD) subject cohort (n = 650) to allow researchers to investigate important unanswered questions in PD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any person with Parkinson's disease who meets the inclusion criteria and does not meet the exclusion criteria.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Short-term disease progression in terms of motor symptoms
Time frame: From baseline till 1 year follow-up
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.
Short-term disease progression in terms of cognitive functioning
Time frame: From baseline till 1 year follow-up
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.
Mid-term disease progression in terms of motor symptoms
Time frame: From baseline till 2 year follow-up
Change in MDS-UPDRS part III score, measured in off state.
Mid-term disease progression in terms of cognitive functioning
Time frame: From baseline till 2 year follow-up
Change in Montreal Cognitive Assessment (MoCA) score
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Derived from this study: PubMed 39476714Heye K, Li R, Bai Q, St George RJ, Rudd K, Huang G, Meinders MJ, Bloem BR, Alty JE. Validation of computer vision technology for analyzing bradykinesia in outpatient clinic videos of people with Parkinson's disease. J Neurol Sci. 2024 Nov 15;466:123271. doi: 10.1016/j.jns.2024.123271. Epub 2024 Oct 15.
- Derived from this study: PubMed 31315608Bloem 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.
- Personalized Parkinson Project study webpageLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
Related trials for Parkinson Disease
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Enrolling by invitation
Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease
Parkinson's Disease, Depression
RecruitingPhase 1/2
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bastiaan R Bloem, MD, PhD principal investigator
Radboud university medical center, department of neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term disease progression in terms of motor symptoms (time frame: From baseline till 1 year follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03364894, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.