The Personalized Parkinson Project De Novo Cohort

NCT04985539 | Active Not Recruiting DMC

• 1 other identifier: NL72631.091.20
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, the Movement Disorders Society (MDS)-UPDRS scale remains the gold standard to document the outcomes in clinical trials for Parkinson's disease (PD). The MDS-UPDRS is far from infallible, as it is based on subjective scoring (using a rather crude ordinal score), while execution of the tests depends on clinical experience. Not surprisingly, the scale is subject to both significant intra- and inter-rater variability that are sufficiently large to mask an underlying true difference between an effective intervention and placebo. Digital biomarkers may be able to overcome the limitations of the MDS-UPDRS, as they continuously collects real-time data, during the patient's day to day activities. In this study the investigators are interested in developing algorithms to track progression of bradykinesia, gait impairment, postural sway, tremor, physical activity, sleep quality, and autonomic dysfunction (the latter being derived from e.g. skin conductance and changes in heart rate variability).

Conditions

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Annual change in digital biomarkers for gait

  Identify (a combined set of) gait-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for gait will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).

  From baseline till two year follow-up

• Annual change in digital biomarkers for tremor

  Identify (a combined set of) tremor-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for tremor will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).

  From baseline till two year follow-up

• Annual change in digital biomarkers for bradykinesia

  Identify (a combined set of) bradykinesia-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for bradykinesia will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).

  From baseline till two year follow-up

• Annual change in digital biomarkers for postural sway

  Identify (a combined set of) postural sway-related features extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for postural sway will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).

  From baseline till two year follow-up

• Annual change in digital biomarkers for time active vs inactive during the day

  Identify (a combined set of) features that reflect the time a person is active and inactive during the day, extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for time active vs inactive during the day will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).

  From baseline till two year follow-up

• Annual change in digital biomarkers for heart rate variability

  Identify (a combined set of) features that reflect heart rate variability, extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for heart rate variability will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).

  From baseline till two year follow-up

• Annual change in digital biomarkers for skin impedance

  Identify (a combined set of) features that reflect skin impedance, extracted from wearable sensor data, that are relevant for patients and that are sensitive to disease progression in de novo PD patients. Which outcome and which Unit of Measure for skin impedance will be selected cannot be defined on forehand, as this is part of the analytical approach, as described by Manta et al. (Digital measures of health that matter to patients. Digit Biomark 2020;4:69-77).

  From baseline till two year follow-up

Secondary Outcomes (12)

• Perceived feasibility of longitudinal follow-up and repeated assessments

  From baseline till two year follow-up

• Compliance to weekly structured tasks

  From baseline till two year follow-up

• Compliance to wearing the smartwatch

  From baseline till two year follow-up

• Drop-out rate

  From baseline till two year follow-up

• Change in PRO-Mobility

  From baseline till two year follow-up, every 13 weeks

Study Arms (1)

PD de novo

Observational.

Device: Verily Study Watch

Interventions

Verily Study Watch DEVICE

Participants wear the Verily Study Watch for 2 years, for longitudinal data collection.

PD de novo

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 adult 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 ≤2 years of duration, defined as the time since the diagnosis was 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, as approved by the Institutional Review Board (IRB).
• Subject is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule and bio-specimen collection.
• Subject has never been treated before with any symptomatic dopaminergic drug treatment for Parkinson's disease and is not expected to start treatment for motor symptoms of PD within 52 weeks from baseline.

You may not qualify if:

• Subject has co-morbidities that would hamper interpretation of parkinsonian disability, such as coincident musculoskeletal abnormalities, in the opinion of the Investigator.
• Subject is taking Mucuna Pruriens.
• For Study Watch: subject is allergic to nickel.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• UCB Pharma: collaborator
• Verily Life Sciences LLC: collaborator

Study Sites (1)

Radboud University Medical Center

Nijmegen, 6500 HB, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimen from all enrolled patients.

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases; Disease Progression

Condition Hierarchy (Ancestors)

Synucleinopathies; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bastiaan R Bloem, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 2, 2021
• Study Start: August 29, 2020
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• 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)