Category: Parkinson’s Disease: Clinical Trials
Objective: Development of a sensor-derived composite score (CS) for progression of motor symptoms in the LUMA study in PD.
Background: LUMA (NCT05348785) is a randomized Phase 2b study examining the efficacy and safety of the LRRK2 inhibitor BIIB122/DNL151 vs. placebo in early-stage PD. Functional tests from a smartphone application are exploratory outcomes of the study.
Method: Participants performed smartphone-administered assessments (Konectom, Indivi AG) weekly at home, including tests of walking (6-minute walk), turning (5 U-turns), and bilateral upper extremity pronation-supination. Baseline data, including 4 weekly remote assessments from 200 randomly selected participants (age, 60.7±8.9 years; MDS-UPDRS part III, 18.4±7.9), and treatment-blinded longitudinal data from 48 weekly assessments from 78 selected participants (age, 61.7±8.9 years; MDS-UPDRS part III, 19.3±7.7) were analyzed. Baseline data were used to preselect reliable candidate sensor-derived measures. Longitudinal data were used to confirm reliability over weeks 23 to 26 (intraclass correlation coefficient ICCw24) and 45 to 48 (ICCw48) and identify measures with higher longitudinal responsiveness at weeks 24 and 48, low mutual correlations, and complementary clinical relevance. Longitudinal responsiveness was assessed by the standardized response mean (SRM), calculated as change from baseline divided by its SD. A CS was the sum of the z score of the selected measures, and its SRM was compared with the SRM of the MDS-UPDRS part III.
Results: Seventeen measures (5 for pronation-supination, 9 for walking, and 3 for turning) were highly reliable according to baseline data. Of these, 4 were selected for the CS: wrist rotation amplitude (average between hands), 95th centile turning speed, 6-minute total distance walked, and median walking cadence. Excellent reliability [table] was maintained when individual measures were combined into the CS, which had a higher SRM than individual scores and MDS-UPDRS part III (SRMw24, 0.15; SRMw48, 0.34).
Conclusion: CS assessing upper limb function and gait showed responsiveness in comparison to MDS-UPDRS part III and individual constitutive digital measures. Longitudinal properties of this smartphone-based sensor-derived composite endpoint may reflect a higher sensitivity to detect disease progression compared with clinical assessment.
Composite abstract table
To cite this abstract in AMA style:
R. Llorens Arenas, E. Bartholome, S. Belachew, C. Bernasconi, G. Cosne, A. Ena, J. Guo, B. Hersh, D. Jennings, A. Juraver, C. Kanzler, A. Karatsidis, F. La Pietra, M. Pang, ó. Reyes, A. Rodríguez-Romero, M. Wald, P. Wang, M. Yang, C. Mazzà. Responsiveness of a Smartphone-Based Sensor-Derived Composite Endpoint in a Phase 2b Study in Parkinson’s Disease (PD) [abstract]. Mov Disord. 2026; 41 (suppl 1). https://www.mdsabstracts.org/abstract/responsiveness-of-a-smartphone-based-sensor-derived-composite-endpoint-in-a-phase-2b-study-in-parkinsons-disease-pd/. Accessed October 1, 2026.« Back to 2026 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/responsiveness-of-a-smartphone-based-sensor-derived-composite-endpoint-in-a-phase-2b-study-in-parkinsons-disease-pd/