Parkinson Disease, Idiopathic, REM Sleep Behavior Disorder
Conditions
Brief 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.
Interventions
OTHERObservational
Observational
PROCEDURESkin 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.
Sponsors
Ronald Postuma
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Digital Biomarkers | 12 months | Changes in continuous sensor-based measurements derived from Roche PD MobileApplication, with active testing and passive monitoring in idiopathic RBD and clinical PD (1 month in Healthy Controls) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| alpha-synuclein deposition in skin biopsy | 12 months | Frequency of pathological alpha-synuclein deposition in the skin biopsy assay in idiopathic RBD and clinical PD and HC (optional study procedure) |
| Changes in sensor-based measurements and passive monitoring | 12 months | Relationship between changes in continuous sensor-based measurements derived from Roche PD Mobile Application active testing and passive monitoring over 12 months in idiopathic RBD, clinical PD and HC and changes in clinical assessments |
| Correlation of sensor-based measurements and imaging outcomes | 12 months | For idiopathic RBD patients only, correlation between sensor-based measurements derived from Roche PD Mobile Application active testing and passive monitoring and changes in MRI and DaT-SPECT outcome measures. |
Countries
Canada
Outcome results
None listed