Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
295 participants
OBSERVATIONAL
2019-03-05
2025-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Observational
Observational
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.
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.
Observational
Observational
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.
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.
Observational
Observational
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.
Interventions
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Observational
Observational
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.
Eligibility Criteria
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Inclusion Criteria
* signed consent form, male or female over age 40, ability to follow protocol, additional group-specific inclusion criteria
Exclusion Criteria:
* participation in interventional clinical study within 3 months of screening, moderate to severe depression in judgement of the investigator, any concomitant disease, condition or treatment which may interfer with the conduct of study (determined by investigator), additional group-specific exclusion criteria
40 Years
ALL
Yes
Sponsors
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Ronald Postuma
OTHER
Responsible Party
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Ronald Postuma
MD, MSc
Locations
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Pacific Parkinson's Research Centre
Vancouver, British Columbia, Canada
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
The Neuro
Montreal, Quebec, Canada
The Neuro
Montreal, Quebec, Canada
Centre de recherche du CHU de Québec-Université Laval (CHUQ)
Québec, , Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PDBS
Identifier Type: -
Identifier Source: org_study_id
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