Parkinson's Disease Biomarker Study (PDBS)

Ronald Postuma

Status: Enrolling

Conditions: REM Sleep Behavior Disorder; Parkinson Disease, Idiopathic

Treatments: Other: Observational; Procedure: Skin Biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT06812702

PDBS

Details and patient eligibility

About

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.

Enrollment: 295 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

295 participants in 3 patient groups

Healthy Control

Description:

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.

Treatment:

Procedure: Skin Biopsy

Other: Observational

RBD Patients

Description:

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.

Treatment:

Procedure: Skin Biopsy

Other: Observational

PD patients

Description:

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.

Treatment:

Procedure: Skin Biopsy

Other: Observational