AI-PROGNOSIS_D5.3 / Report on the status of posting results (dBM-DEV study)

Executive summary This deliverable reports on the results of the Digital Biomarkers Development Study (dBM-DEV study) (NCT06444789). The aim of the dBM-DEV study was to develop and assess the feasibility and validity of smartwatch-based digital biomarkers (dBMs) and mobile app-based user active tests for different motor and non-motor symptoms of Parkinson’s disease (PD). The primary objective was to develop smartwatch-based digital biomarkers for Rapid Eye Movement Sleep Behaviour Disorders (RBD) using data from a development cohort and external datasets, and to assess their validity in a confirmation cohort. Fifty-three (53) participants were enrolled in the development cohort [24 controls, 27 with idiopathic RBD (iRBD), 2 with RBD and PD] and 28 participants in the confirmation cohort, all with PD. The primary study end point was the specificity of the dBMs for RBD in comparison to the standardised RBD Screening Questionnaire (RBDSQ), with polysomnography-confirmed RBD as the ground truth. The analysis for the primary end point was inconclusive because the number of participants in the confirmation cohort without RBD (negatives) was eventually too low. Results of this study will be used to adequately address this issue in future research. Five out of seven secondary endpoints and four out of five exploratory endpoints were positive. Positive secondary endpoints include the feasibility of smartwatch-based dBMs for bradykinesia, dyskinesias, and rest tremor, cognitive active tests, and for touchscreen typing-based assessment of fine movement. Positive exploratory endpoints include significant correlation of the smartwatch-based dBMs for rest tremor and slowness of gross movements of the upper extremities, as well as of the typing-based assessment of fine movement with the corresponding Movement Disorders Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) clinical scores. Results will be posted to the registry where the clinical study was registered (clinicaltrials.gov, NCT06444789) at the latest by the end of the project. Data monitoring and analysis will continue beyond February 2026.