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AI-PROGNOSIS dBM-DEV study received ethical approval in Spain

17 May 2024

A Milestone Achievement - Ethical Approval Granted for AI-PROGNOSIS dBM-DEV Study in Spain

The AI-PROGNOSIS project partner, Fundación Iniciativa Para las Neurociencias (FOUNDATION FOR INITIATIVES IN NEUROSCIENCE), has achieved a significant milestone by receiving ethical approval for the Digital biomarkers development, validation and verification study (dBM-DEV study) in Spain.

The ethics approvals for TECHNISCHE UNIVERSITAET DRESDEN (Dresden University of Technology, Germany) and King's College London (UK) are in progress.

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 scheduled for June 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.

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