The Digital Biomarkers Development, Validation and Verification study (dBM-DEV study) has officially been initiated, with the first patient enrolled at CHU de Toulouse in early October.

This study is part of the AI-PROGNOSIS project and focuses on developing digital biomarkers (dBMs) for Parkinson’s disease (PD) symptoms, particularly REM sleep behaviour disorder (RBD) and daytime sleepiness. By the end of October, patient recruitment is planned in all clinical sites: King’s College London in the UK, Fundación INCE (Iniciativa para las Neurociencias) in Spain, and Technical University of Dresden in Germany.

Importance of the Study

REM behaviour disorder (RBD) is the best predictor for neurodegenerative diseases with synuclein pathology, including Parkinson’s disease. 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 dBM-DEV study will be conducted on 90 participants from Germany, France, Spain, and the UK, who will undergo daily-life digital biomarker tracking.

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

Discover More

For a deeper understanding of the dBM-DEV study and its significance, watch our latest video interview featuring Prof. Dr. Björn Falkenburger from Technical University of Dresden. He discusses the study's objectives and the potential impact on the management of PD.