Department of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Neurology Service, Hospital Clinic de Barcelona, IDIBAPS, CIBERNED, Spain.
Sleep Med. 2021 May;81:180-187. doi: 10.1016/j.sleep.2021.02.038. Epub 2021 Feb 25.
Rapid eye movement sleep behavior disorder (RBD) is frequent in dementia with Lewy bodies (DLB) and Parkinson's disease dementia (PDD), and poses a risk of injury to patients and their bed partners. We assessed the efficacy of nelotanserin, a selective 5-HT (2A) inverse agonist, for symptomatic treatment of RBD using systematic video analysis.
This was a phase 2 multicenter study in DLB or PDD with video polysomnography (vPSG)-confirmed RBD. After a single-blind placebo run-in period, patients meeting eligibility criteria entered a 4-week double-blind treatment period (1:1 ratio with nelotanserin 80 mg/placebo). Whole-night vPSG was conducted during the run-in and at the end of the treatment period. Videos of all rapid eye movement (REM) sleep periods were analysed for RBD behaviors (movements and vocalizations) using the Innsbruck classification system by two of the central reviewers, and a third reviewer adjudicated ambiguous cases.
34 patients (N = 26 DLB, N = 8 PDD; 85.3% men; mean age 71.3 ± 6.36 years) were included in the analyses. Two (5.9%) patients were excluded due to protocol deviation in treatment compliance. Systematic video analysis demonstrated no difference between nelotanserin and placebo in RBD behaviors. Bland-Altman plot showed high interrater reliability.
Despite negative results, this is the first randomized, placebo-controlled study on symptomatic RBD treatment using objective outcome measures based on systematic video analysis. This study provides a new method for outcome research in RBD and proves that movement analysis is a feasible and meaningful outcome for studies evaluating changes in RBD severity.
ClinicalTrials.gov. NCT Number NCT02708186. https://clinicaltrials.gov/ct2/show/NCT02708186.
快速眼动睡眠行为障碍（RBD）在路易体痴呆（DLB）和帕金森病痴呆（PDD）中很常见，并且会对患者及其床伴造成伤害的风险。我们使用系统视频分析评估了选择性 5-HT（2A）反向激动剂 nelotanserin 治疗 RBD 的症状的疗效。
这是一项在视频多导睡眠图（vPSG）证实有 RBD 的 DLB 或 PDD 中进行的 2 期多中心研究。在单盲安慰剂导入期后，符合入选标准的患者进入为期 4 周的双盲治疗期（nelotanserin 80mg/安慰剂 1:1 比例）。在导入期和治疗期末进行整夜 vPSG。使用因斯布鲁克分类系统，由两位中心审查员对所有 REM 睡眠期的视频进行分析，以评估 RBD 行为（运动和发声），并由第三位审查员对模棱两可的病例进行裁决。
34 名患者（N=26 DLB，N=8 PDD；85.3%为男性；平均年龄 71.3±6.36 岁）纳入分析。由于治疗依从性的方案偏差，有 2 名（5.9%）患者被排除。系统视频分析显示 nelotanserin 与安慰剂在 RBD 行为方面无差异。Bland-Altman 图显示了高的审查者间可靠性。
尽管结果为阴性，但这是第一项使用基于系统视频分析的客观结局测量对症状性 RBD 治疗进行的随机、安慰剂对照研究。本研究为 RBD 的结局研究提供了一种新方法，并证明运动分析是评估 RBD 严重程度变化的研究中一种可行且有意义的结局。
ClinicalTrials.gov。NCT Number NCT02708186。https://clinicaltrials.gov/ct2/show/NCT02708186。
