The Phase II trial of Anti-alpha-Synuclein Antibody in Early Parkinson’s Disease (PASADENA) is an ongoing double-blind, placebo-controlled trial evaluating the safety and efficacy of prasinezumab in early-stage Parkinson’s disease (PD). During the double-blind period, prasinezumab-treated individuals showed less progression of motor signs (Movement Disorders Society-sponsored revision of the Unified Parkinson’s Disease Rating Scale (MDS–UPDRS) Part III) than placebo-treated individuals. We evaluated whether the effect of prasinezumab on motor progression, assessed as a change in MDS–UPDRS Part III score in the OFF and ON states, and MDS–UPDRS Part II score, was sustained for 4 years from the start of the trial. We compared participants enrolled in the PASADENA open-label extension study with those enrolled in an external comparator arm derived from the Parkinson’s Progression Markers Initiative observational study. The PASADENA delayed-start (n = 94) and early-start (n = 177) groups showed a slower decline (a smaller increase in score) in MDS–UPDRS Part III scores in the OFF state (delayed start, −51%; early start, −65%), ON state (delayed start, −94%; early start, −118%) and MDS–UPDRS Part II (delayed start, −48%; early start, −40%) than did the Parkinson’s Progression Markers Initiative external comparator (n = 303). This exploratory analysis, which requires confirmation in future studies, suggested that the effect of prasinezumab in slowing motor progression in PD may be sustained long term. PASADENA ClinicalTrials.gov no. NCT03100149.

早期帕金森病抗 α-突触核蛋白抗体 （PASADENA） 的 II 期试验是一项正在进行的双盲、安慰剂对照试验，旨在评估普拉辛珠单抗在早期帕金森病 （PD） 中的安全性和有效性。在双盲期间，与安慰剂治疗个体相比，prasinezumab 治疗的个体表现出更少的运动体征进展 （运动障碍协会赞助的统一帕金森病评定量表 （MDS-UPDRS） 第 III 部分修订版）。我们评估了 prasinezumab 对运动进展的影响，评估为 OFF 和 ON 状态下 MDS-UPDRS 第 III 部分评分的变化，以及 MDS-UPDRS 第 II 部分评分，是否从试验开始持续 4 年。我们将参加 PASADENA 开放标签扩展研究的参与者与参加来自帕金森病进展标志物倡议观察研究的外部对照组的参与者进行了比较。PASADENA 延迟开始 （n = 94） 和提前开始 （n = 177） 组在关闭状态（延迟开始，-51%;提前开始，-65%）、开启状态（延迟开始，-94%;提前开始，-118%）和 MDS-UPDRS 第二部分（延迟开始，-48%;提前开始，-40%）的 MDS-UPDRS 第三部分评分下降较慢（分数增加较小），低于帕金森病进展标志物倡议外部对照器（n= 303）。这项探索性分析需要在未来的研究中得到证实，它表明 prasinezumab 在减缓 PD 运动进展方面的效果可能会长期持续。帕萨迪纳 ClinicalTrials.gov 没有。NCT03100149。