Parkinson's Disease Biomarker Study

NCT06812702 | Completed

• 1 other identifier: PDBS
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

REM Sleep Behavior Disorder; Parkinson Disease, Idiopathic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• alpha-synuclein deposition in skin biopsy

  12 months

• Changes in sensor-based measurements and passive monitoring

  12 months

• Correlation of sensor-based measurements and imaging outcomes

  12 months

Study Arms (3)

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; Procedure: Skin Biopsy

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; Procedure: Skin Biopsy

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; Procedure: Skin Biopsy

Interventions

Observational OTHER

Observational

Healthy Control; PD patients; RBD Patients

Skin Biopsy PROCEDURE

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.

Healthy Control; PD patients; RBD Patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

male or female over age 40, ability to follow protocol

Sponsors & Collaborators

• Ronald Postuma: lead

Study Sites (4)

Pacific Parkinson's Research Centre

Vancouver, British Columbia, V6T 2B5, Canada

Location

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0A9, Canada

Location

The Neuro

Montreal, Quebec, H3A 2B4, Canada

Location

Centre de recherche du CHU de Québec-Université Laval (CHUQ)

Québec, Quebec, G1J 1Z4, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Optional skin biopsy will be collected paravertebrally at approximately the C8 level at baseline. This procedure is performed to validate an immunohistochemistry skin biopsy assay for the detection of pathological alpha-synuclein diagnostic of PD. Follow up skin samples of consenting participants will be collected at the one-year follow-up.

MeSH Terms

Conditions

Parkinson Disease; REM Sleep Behavior Disorder

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; REM Sleep Parasomnias; Parasomnias; Sleep Wake Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: March 5, 2019
• Primary Completion: December 31, 2025
• Study Completion: March 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)