Exploratory Sensor-based Outcome Measures Show Divergent Slopes of Motor Sign Progression in Parkinson’s Disease Patients Treated with Prasinezumab
Abstract Digital health technology (DHT) tools for Parkinson’s disease (PD) such as smartphones and wearable sensors enable remote and frequent measurement of motor signs which may facilitate research on novel treatments for PD. Here, we report the effect of the anti-alpha-synuclein monoclonal antibody prasinezumab on two-year motor sign progression in an early-stage PD population as measured with the Roche PD Mobile Application DHT. 316 early-stage PD participants of the phase 2 PASADENA study (NCT03100149) were randomized to treatment with placebo, 1500 mg, or 4500 mg prasinezumab for 52 weeks (Part 1); and placebo treated patients in Part 1 were re-randomized to 1500 mg or 4500 mg prasinezumab for the ensuing 52 weeks (Part 2, delayed-start group). Patients performed daily motor ‘active tests’ on provisioned study smartphones, carried the phone and wore a smartwatch throughout the day for passive monitoring, over two years. Change from baseline on 17 pre-specified individual sensor features and a summary Simple Sum score were analyzed with linear random slope and intercept models or mixed models for repeated measures, censoring patient data following the start of dopaminergic treatment. Adherence to active testing averaged 5.7 and 5.0 days/week in Parts 1 and 2, respectively. Bilateral speeded tapping variability and hand turning, U-turn speed, the power of passively monitored non-gait hand movements, and the Simple Sum score progressed less in prasinezumab-treated vs placebo at week 52. All findings except hand turning persisted at week 104. While the primary outcome for Part 1 PASADENA (MDS-UPDRS sum of Parts I, II and III) showed no significant difference from placebo, exploratory sensor-based outcome measures showed reduced motor sign progression in prasinezumab-treated individuals with early-stage PD..
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Preprint| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ResearchSquare.com - (2024) vom: 06. Feb. Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Beteiligte Personen: |
Taylor, Kirsten [VerfasserIn] |
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| Links: |
Volltext [kostenfrei] |
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| doi: |
10.21203/rs.3.rs-3921378/v1 |
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| 520 | |a Abstract Digital health technology (DHT) tools for Parkinson’s disease (PD) such as smartphones and wearable sensors enable remote and frequent measurement of motor signs which may facilitate research on novel treatments for PD. Here, we report the effect of the anti-alpha-synuclein monoclonal antibody prasinezumab on two-year motor sign progression in an early-stage PD population as measured with the Roche PD Mobile Application DHT. 316 early-stage PD participants of the phase 2 PASADENA study (NCT03100149) were randomized to treatment with placebo, 1500 mg, or 4500 mg prasinezumab for 52 weeks (Part 1); and placebo treated patients in Part 1 were re-randomized to 1500 mg or 4500 mg prasinezumab for the ensuing 52 weeks (Part 2, delayed-start group). Patients performed daily motor ‘active tests’ on provisioned study smartphones, carried the phone and wore a smartwatch throughout the day for passive monitoring, over two years. Change from baseline on 17 pre-specified individual sensor features and a summary Simple Sum score were analyzed with linear random slope and intercept models or mixed models for repeated measures, censoring patient data following the start of dopaminergic treatment. Adherence to active testing averaged 5.7 and 5.0 days/week in Parts 1 and 2, respectively. Bilateral speeded tapping variability and hand turning, U-turn speed, the power of passively monitored non-gait hand movements, and the Simple Sum score progressed less in prasinezumab-treated vs placebo at week 52. All findings except hand turning persisted at week 104. While the primary outcome for Part 1 PASADENA (MDS-UPDRS sum of Parts I, II and III) showed no significant difference from placebo, exploratory sensor-based outcome measures showed reduced motor sign progression in prasinezumab-treated individuals with early-stage PD. | ||
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