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

Status: Recruiting
Location: See all (5) 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
View:

• 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)
RECRUITING
Montreal
The Neuro
RECRUITING
Montreal
The Neuro
RECRUITING
Montreal
Centre de recherche du CHU de Québec-Université Laval (CHUQ)
RECRUITING
Québec
Pacific Parkinson's Research Centre
RECRUITING
Vancouver
Contact Information
Primary
Nisha Pulimood, PhD
nisha.pulimood@mcgill.ca
+1 514-396-2401
Time Frame
Start Date: 2019-03-05
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 295
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