Parkinson Disease, IdiopathicPDBSNCT06812702
Parkinson's Disease Biomarker Study
An observational study of Parkinson Disease, Idiopathic and REM Sleep Behavior Disorder, run by Ronald Postuma at 4 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Idiopathic, REM Sleep Behavior Disorder
- What is being tested?
- Observational and Skin Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 230 participants
- Where
- 4 sitesCanada
- Study dates
- 5 Mar 2019to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: male or female over age 40, ability to follow protocol
Who may be able to join
- signed consent form, male or female over age 40, ability to follow protocol, additional group-specific inclusion criteria
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0A9
The Neuro
Montreal, Quebec, H3A 2B4
Centre de recherche du CHU de Québec-Université Laval (CHUQ)
Québec, Quebec, G1J 1Z4
Pacific Parkinson's Research Centre
Vancouver, British Columbia, V6T 2B5
About this study
Official title: A Multi-site Longitudinal Cohort Study of Prodromal and Clinical Parkinson'sDisease
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.
- Being tested
- Observational, Skin Biopsy
- Medical subject headings
- Parkinson Disease, REM Sleep Behavior Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
Observational
Skin BiopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Observational; Procedure: Skin Biopsy | |
| 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. Receives: Other: Observational; Procedure: Skin Biopsy | |
| 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. Receives: Other: Observational; Procedure: Skin Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Biomarkers
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)
Measured: 12 months
Secondary outcomes (3)
alpha-synuclein deposition in skin biopsy
Frequency of pathological alpha-synuclein deposition in the skin biopsy assay in idiopathic RBD and clinical PD and HC (optional study procedure)
Measured: 12 months
Changes in sensor-based measurements and passive monitoring
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
Measured: 12 months
Correlation of sensor-based measurements and imaging outcomes
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start5 Mar 2019
- Primary completion31 Dec 2025
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease, IdiopathicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ronald Postuma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ronald Postuma, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06812702
- Sponsor's protocol ID
- PDBS
- Acronym
- PDBS
- Status last verified
- Dec 2025
- First submitted
- 2 Feb 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site Longitudinal Cohort Study of Prodromal and Clinical Parkinson'sDisease
- ClinicalTrials.gov ID
- NCT06812702
- Acronym / sponsor ID
- PDBS / PDBS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Ronald PostumaUniversity, hospital or other
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | Other: Observational, Procedure: Skin BiopsyAbove 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 | – | Other: Observational, Procedure: Skin BiopsyPolysomnographic 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 | – | Other: Observational, Procedure: Skin BiopsyPatients 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- male or female over age 40, ability to follow protocol
Key inclusion criteria (1 listed)
- signed consent form, male or female over age 40, ability to follow protocol, additional group-specific inclusion criteria
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ObservationalObservational | Other | Healthy Control, PD patients, RBD Patients |
| Skin BiopsyParticipants 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. | Procedure or surgery | Healthy Control, PD patients, RBD Patients |
Primary outcome
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)
3 secondary outcomes
alpha-synuclein deposition in skin biopsy
Time frame: 12 months
Changes in sensor-based measurements and passive monitoring
Time frame: 12 months
Correlation of sensor-based measurements and imaging outcomes
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, Idiopathic and REM Sleep Behavior Disorder, run by Ronald Postuma at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Biomarkers (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.