Parkinson's Disease Biomarker Study

Last updated: February 2, 2025
Sponsor: Ronald Postuma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sleep Disorders

Treatment

Observational

Skin Biopsy

Clinical Study ID

NCT06812702
PDBS
  • Ages > 40
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 295
Treatment Group(s): 2
Primary Treatment: Observational
Phase:
Study Start date:
March 05, 2019
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Pacific Parkinson's Research Centre

    Vancouver, British Columbia V6T 2B5
    Canada

    Active - Recruiting

  • Centre hospitalier de l'Université de Montréal (CHUM)

    Montreal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • The Neuro

    Montreal, Quebec H3A 2B4
    Canada

    Active - Recruiting

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

    Québec, G1J 1Z4
    Canada

    Active - Recruiting

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