Parkinson's Disease Clinical Trials

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

Status: Completed
Location: See all (4) locations...
Intervention Type: Other, Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: t
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• signed consent form, male or female over age 40, ability to follow protocol, additional group-specific inclusion criteria

Locations
Other Locations
Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal
The Neuro
Montreal
Centre de recherche du CHU de Québec-Université Laval (CHUQ)
Québec
Pacific Parkinson's Research Centre
Vancouver
Time Frame
Start Date: 2019-03-05
Completion Date: 2026-03-01
Participants
Target number of participants: 230
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Ronald Postuma

This content was sourced from clinicaltrials.gov