Exploratory digital outcome measures of motor sign progression in Parkinson’s disease patients treated with prasinezumab
Kirsten I. Taylor, Florian Lipsmeier, Marzia A. Scelsi, Ekaterina Volkova-Volkmar, Daria Rukina, Werner Popp, Stefan Lambrecht, Judith Anzures‐Cabrera, David Summers, Markus Abt, Annabelle Monnet, Timothy Kilchenmann, Jens Schjodt‐Eriksen, Laurent Essioux, Thomas Kustermann, Wagner Zago, Hanno Svoboda, Tania Nikolcheva, Ronald B. Postuma, Gennaro Pagano, Michael Lindemann, PASADENA Investigators, Claudia Altendorf, Chareyna Anandan, Giulia Andrews, Solène Ansquer, Raphaele Arrouasse, Sana Aslam, Jean-Philippe Azula, Jeanette Baker, Ernest Balaguer Martinez, Shadi Barbu, Kara Bardram, Danny Bega, H. Marco, Isabelle Bénatru, Eve Benchetrit, Felix Bernhard, Aris Raad Besharat, Sagari Betté, Amélie Bichon, Andrew Billnitzer, Sophie Blondeau, Thomas Boraud, Friederike Borngräber, James T. Boyd, Kathrin Brockmann, Matthew Brodsky, Ethan Brown, Christof Bruecke, Fabienne Calvas, Monica Canelo, Federico Carbone, Claire Carroll, Laura Casado‐Fernández, Catherine Casse-Parrot, Anna Castrioto, Hélène Catalá, Justine Chan, Samia Cheriet, Anthony Ciabarra, Joseph Claßen, Juliana Coleman, Robert R. Coleman, Yaroslau Compta, Jean-Christophe Corvol, Mariana Cosgaya, Nabila Dahodwala, Philippe Damier, Elodie David, Thomas L. Davis, Marissa Dean, Bérengère Debilly, Janell DeGiorgio, Andres Deik, Laure Delaby, Marie-Helene Delfini, Pascal Derkinderen, Philippe Derost, María de Toledo, Lisa M. Deuel, Ann Marie Diaz Hernandez, Cameron Dietiker, Karina Dimenshteyn, Julio Dotor, Franck Durif, Jens Ebentheuer, Karla Eggert, Sara Eichau, Claudia Eickoff, Aaron Ellenbogen, Philipp Ellmerer, Inés Esparragosa Vázquez, Alexandre Eusébio, Siobhán Ewert, John Fang, Danielle Feigenbaum, Frédérique Fluchère, Alexandra Foubert‐Samier, Marie Fournier
Abstract
Digital health technology (DHT) tools for Parkinson's disease (PD) e.g., smartphones and wearables were used for remote and frequent measurement of motor signs in the phase 2 PASADENA study of the anti-alpha-synuclein monoclonal antibody prasinezumab. 316 early-stage PD participants were randomized to placebo, 1500 mg, or 4500 mg prasinezumab for 52 weeks; placebo participants were re-randomized to prasinezumab for the ensuing 52 weeks. Patients performed daily smartphone motor "active tests", and were passively monitored by smartphone/smartwatch throughout the day over 2 y. Change from baseline analyses censored data at dopaminergic treatment start. Bilateral speeded tapping variability and hand-turning, U-turn speed, passively monitored hand movement power, and summary Simple Sum scores progressed numerically less in prasinezumab-treated vs placebo at week 52. All findings except hand-turning persisted at week 104. DHT sensor-based outcome measures may contribute to quantifying disease progression in clinical research of early-stage, dopaminergic treatment-naïve PD. Clinical Trial Registry Name: ClinicalTrials.gov; Clinical Trial Registry ID: NCT03100149; registered 2017-03-29.