NCT06812702

Parkinson's Disease Biomarker Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 230 (actual)
• Sponsor: Ronald Postuma · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

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

• Parkinson Disease, Idiopathic
• REM Sleep Behavior Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-03-05
• Primary completion: 2025-12-31
• Completion: 2026-03-01
• First posted: 2025-02-06
• Last updated: 2026-03-13

Locations

4 sites across 1 country: Canada