Parkinson's Disease Biomarker Study (PDBS)

A Multi-site Longitudinal Cohort Study of Prodromal and Clinical Parkinson'sDisease

The primary objective of this study is to determine whether data acquired from a remote monitoring approach can reliably identify and track motor symptoms in prodromal PD and clinical PD.

The study is a one-year longitudinal biomarker study recruiting idiopathic RBD patients, Parkinson's Disease patient and healthy controls. All participants receive a smartphone with the Roche PD Mobile Application, complete a number of active tests daily and their movements will be remotely monitored. Participants will undergo additional neurological exams and DaT-SPECT and MRI imaging in the study.

A second objective of this study will be to validate an immunohistochemistry skin biopsy assay for the detection of pathological alpha-synuclein diagnostic of PD, in the peripheral nerves of the skin.

Study Overview

• Status: Completed
• Conditions: REM Sleep Behavior Disorder; Parkinson Disease, Idiopathic
• Intervention / Treatment: Other: Observational; Procedure: Skin Biopsy

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2B5
      • Pacific Parkinson's Research Centre
  • Quebec
    • Montreal, Quebec, Canada, H2X 0A9
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
    • Montreal, Quebec, Canada, H3A 2B4
      • The Neuro
    • Québec, Quebec, Canada, G1J 1Z4
      • Centre de recherche du CHU de Québec-Université Laval (CHUQ)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

male or female over age 40, ability to follow protocol

Description

Inclusion Criteria:

• signed consent form, male or female over age 40, ability to follow protocol, additional group-specific inclusion criteria

Exclusion Criteria:

• participation in interventional clinical study within 3 months of screening, moderate to severe depression in judgement of the investigator, any concomitant disease, condition or treatment which may interfer with the conduct of study (determined by investigator), additional group-specific exclusion criteria

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Control; Above 40 years of age, sex matched with PD cohort. Participants may consent to additional skin biopsy at baseline and at the one-year follow-up. Skin will be taken paravertebrally at approximately the C8 level.	Other: Observational; Observational; Procedure: Skin Biopsy; Participants may consent to additional skin biopsy at baseline and at the one-year follow-up. Skin will be taken paravertebrally at approximately the C8 level.
RBD Patients; Polysomnographic confirmed RBD, age 50 years or older, male and female. RBD patients only will receive DaT-SPECT and MRI imaging at baseline and Week52 of the study. Participants may consent to additional skin biopsy at baseline and at the one-year follow-up. Skin will be taken paravertebrally at approximately the C8 level.	Other: Observational; Observational; Procedure: Skin Biopsy; Participants may consent to additional skin biopsy at baseline and at the one-year follow-up. Skin will be taken paravertebrally at approximately the C8 level.
PD patients; Patients with PD first diagnosed 2-6 years prior to enrolment, above 40 years of age, male and female. Participants may consent to additional skin biopsy at baseline and at the one-year follow-up. Skin will be taken paravertebrally at approximately the C8 level.	Other: Observational; Observational; Procedure: Skin Biopsy; Participants may consent to additional skin biopsy at baseline and at the one-year follow-up. Skin will be taken paravertebrally at approximately the C8 level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Digital Biomarkers	Changes in continuous sensor-based measurements derived from Roche PD MobileApplication, with active testing and passive monitoring in idiopathic RBD and clinical PD (1 month in Healthy Controls)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
alpha-synuclein deposition in skin biopsy	Frequency of pathological alpha-synuclein deposition in the skin biopsy assay in idiopathic RBD and clinical PD and HC (optional study procedure)	12 months
Changes in sensor-based measurements and passive monitoring	Relationship between changes in continuous sensor-based measurements derived from Roche PD Mobile Application active testing and passive monitoring over 12 months in idiopathic RBD, clinical PD and HC and changes in clinical assessments	12 months
Correlation of sensor-based measurements and imaging outcomes	For idiopathic RBD patients only, correlation between sensor-based measurements derived from Roche PD Mobile Application active testing and passive monitoring and changes in MRI and DaT-SPECT outcome measures.	12 months

Collaborators and Investigators

• Sponsor: Ronald Postuma

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2019
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): March 1, 2026

Study Registration Dates

• First Submitted: February 2, 2025
• First Submitted That Met QC Criteria: February 2, 2025
• First Posted (Actual): February 6, 2025

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurodegenerative Diseases; Sleep Wake Disorders; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parasomnias; REM Sleep Parasomnias; Parkinson Disease; REM Sleep Behavior Disorder; Health Services Administration; Quality of Health Care; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Watchful Waiting
• Other Study ID Numbers: PDBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No