Category: Parkinson’s Disease: Clinical Trials
Objective: To investigate the effect of concurrent symptomatic treatment (ST) on digital measures collected in ORCHESTRA (NCT04658186).
Background: Minzasolmin is an oral small molecule that targets α-syn misfolding—the initial step in the pathological cascade of Parkinson’s disease (PD)—to prevent future α-syn aggregation, Lewy body formation, and neuron loss. ORCHESTRA was a multicenter, double-blind, Phase II study that failed to show effects on any clinical endpoint. Patients with early-stage PD naive to ST were randomized (1:1:1) to receive low-or high-dose, or placebo. Virtual Motor Exams (VMEs) were optionally implemented using the Verily study watch.
Method: VMEs were performed in the OFF state during in-clinic (IC) visits (every 2 months) and at-home (AT, once a week) for 18 months. Four composites (V-gait, V-bradykinesia, V-tremor and V-overall motor) were derived from the VMEs. To investigate the ST effect, linear random coefficients mixed-effects models were used, in which time (weeks), ST × time, and baseline characteristics (age, sex and disease duration) were entered as fixed effects, with subject as random intercept. The ST variable was a time-varying covariate, equal to 1 when patients were treated with ST, or 0 otherwise. Estimates and 95% confidence intervals (CIs) of the interaction term ST x time were reported.
Results: A total of 93 patients wore the watch Overall, 18%, 40% and 52% of participants were on ST at Month 6, 12 and 18, respectively. IC data showed that ST improved symptoms captured by the composites (V-bradykinesia: -0.033, [95% CI -0.040, -0.026]; V-gait: -0.006, [-0.010, -0.002]; V-tremor: -0.019, [-0.027, -0.012]; V-overall motor: -0.179, [-0.217, -0.141]) and this result was confirmed by AT data (V-bradykinesia: -0.034, [-0.036, -0.031]; V-gait: -0.007, [-0.008, -0.005]; V-tremor: -0.022, [-0.025, -0.019]; V-overall motor: -0.187, [-0.203, -0.170]).
Conclusion: The confounding effect of ST was confirmed by composite digital measures from a wearable device. These findings indicate the need for censoring when evaluating disease-modifying treatments (DMT). However, more analysis is needed to evaluate the influence of ST on single features on top of DMT.
To cite this abstract in AMA style:
B. Bloem, V. Hinson, L. Gaetano, E. Goikoetxea, K. Ray, F. Ambrosetti, V. Ticcinelli, M. Key Prato, A. Pethe, C. Serrano Amenos, J. Trzebinski, S. Warma, A. Khanna, Z. Ali. Wearable-based digital measures from the Verily Study Watch can detect concurrent symptomatic treatment effects in a subset of early-stage Parkinson’s disease ORCHESTRA trial participants [abstract]. Mov Disord. 2025; 40 (suppl 1). https://www.mdsabstracts.org/abstract/wearable-based-digital-measures-from-the-verily-study-watch-can-detect-concurrent-symptomatic-treatment-effects-in-a-subset-of-early-stage-parkinsons-disease-orchestra-trial-participants/. Accessed October 9, 2026.« Back to 2025 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/wearable-based-digital-measures-from-the-verily-study-watch-can-detect-concurrent-symptomatic-treatment-effects-in-a-subset-of-early-stage-parkinsons-disease-orchestra-trial-participants/