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OpenTrials
Completed

NCT Number: NCT06812702

Parkinson's Disease Biomarker Study

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.

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Key information

Conditions

Parkinson Disease, Idiopathic Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parasomnias Parkinson Disease Parkinsonian Disorders REM Sleep Behavior Disorder REM Sleep Parasomnias Sleep Wake Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pacific Parkinson's Research Centre, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observational

Other

Observational

skin biopsy

Procedure

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.

Primary outcomes

  1. Digital Biomarkers

    Time frame: 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 outcomes

  1. alpha-synuclein deposition in skin biopsy

    Time frame: 12 months

    Frequency of pathological alpha-synuclein deposition in the skin biopsy assay in idiopathic RBD and clinical PD and HC (optional study procedure)

  2. Changes in sensor-based measurements and passive monitoring

    Time frame: 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

  3. Correlation of sensor-based measurements and imaging outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ronald Postuma

Other

Registry information

Official study title

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

Acronym: PDBS

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Feb 6, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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