We are heading towards the launch of the Digital biomarkers development, validation and verification study (dBM-DEV study). The latest update comes from our UK partner, King’s College London, which has now received the ethical approval required to proceed with the study.

This milestone marks the final step in securing ethical approvals across all participating countries. Ethical approvals have already been granted for Fundación INCE (Iniciativa para las Neurociencias) and CHU de Toulouse in Spain and France, as well as Technische Universität Dresden in Germany.

The Digital biomarkers development, validation and verification study (dBM-DEV study) overview:

REM behaviour disorder (RBD) is the best predictor for neurodegenerative diseases with synuclein pathology, including Parkinson’s disease (PD). RBD affects 0.5-1 % of the general population. It can only be diagnosed by polysomnography, which is a cumbersome procedure that cannot be used for screening. An RBD screening questionnaire (RBDSQ) has been developed with high sensitivity but low specificity. Thus, digital assessments can potentially be used to identify people with a high probability of RBD for polysomnography to facilitate the detection of prodromal PD.

The study will be conducted on 90 participants who will undergo daily-life digital biomarker tracking. The first patient enrollment is expected in September 2024.

It is anticipated that the identification of robust dBMs in this study will have a favourable impact on the PD community in the future by enabling the daily-life detection and monitoring of PD symptoms, including the early signs of the disease, such as RBD.