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NE3107在早期帕金森病中的研究 (SUNRISE-PD)

2026年8月7日 更新者：BioVie Inc.

NE3107 在早期帕金森病受试者中的双盲、随机、安慰剂对照研究

这项临床试验的目的是了解贝齐斯特林是否可以治疗 45 至 80 岁的帕金森病患者的运动症状，这些患者身体和心理健康状况良好，并且即将需要治疗来缓解症状，但尚未接受治疗。尚未开出任何形式的左旋多巴或具有类似活性的药物。 它旨在回答的主要问题是：

  • 贝齐斯特林会减少帕金森病的运动症状吗？
  • 参与者在服用贝齐斯特林时会出现哪些医疗问题？

研究人员将比较贝齐斯特林治疗与安慰剂（一种不含药物的相似物质）的效果，看看贝齐斯特林是否能治疗帕金森病的运动症状。

参与者将

  • 进行包括心电图在内的身体检查
  • 每天服用两次药物或安慰剂，持续四个月
  • 在五个月内访问临床现场或接受家访七次

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

57

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Michigan
      • Farmington Hills、Michigan、美国、48334
        • Quest Research Institute
    • New York
      • Amherst、New York、美国、14226
        • Dent Neurologic
    • North Carolina
      • Morrisville、North Carolina、美国、27560
        • Science 37 (Nationwide Site)
    • Ohio
      • Canton、Ohio、美国、44718
        • Neuroscience Research Center, LLC

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

纳入标准：

  • 45岁至80岁
  • 18 个月内诊断出患有特发性帕金森病 (PD)
  • 接近需要对症治疗
  • 同意使用节育措施
  • 提供自愿同意
  • 愿意采集血液进行 DNA 甲基化分析
  • 通过所有筛选测试和程序

排除标准：

  • 已服用左旋多巴或其他类似药物来治疗帕金森病的运动症状
  • PD 诊断的已知或强烈怀疑的家族原因
  • 重大心理健康或身体疾病
  • 重大精神或身体疾病病史

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：NE3107
受试者将接受 20 mg BID 的 NE3107（每日两次；每日 40 mg）口服胶囊。
药品：NE3107
NE3107 20 毫克 BID
其他名称：
  • 贝齐斯特林
安慰剂比较：安慰剂
受试者将收到匹配的安慰剂胶囊，每日两次口服给药。
药品：安慰剂
安慰剂出价

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Monocyte Lymphocyte Ratio (MLR)
大体时间：12 Weeks
A unitless inflammatory biomarker calculated by dividing the absolute peripheral blood monocyte count by the absolute peripheral blood lymphocyte count, using values derived from clinical hematology (complete blood count with differential)
12 Weeks

次要结果测量

结果测量
措施说明
大体时间
Change in Systemic Inflammation Response Index (SIRI)
大体时间：12 weeks
A unitless measure of systemic inflammation calculated as the product of the absolute blood neutrophil count and absolute blood monocyte count divided by the absolute blood lymphocyte count in samples obtained for clinical hematology testing.
12 weeks
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
大体时间：12 weeks
A unitless measure of systemic inflammation calculated as the ratio of the absolute peripheral blood neutrophil count to the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
12 weeks
Change in Systemic Immune-Inflammation Index (SII)
大体时间：12 weeks
A unitless composite measure of systemic inflammation and immune status calculated as the product of the absolute peripheral blood platelet count and neutrophil count divided by the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
12 weeks
Change in Platelet-to-Lymphocyte Ratio (PLR)
大体时间：12 weeks
A unitless measure of systemic inflammation calculated as the ratio of the absolute peripheral blood platelet count to the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
12 weeks
Change in Aggregate Index of Systemic Inflammation (AISI)
大体时间：12 weeks
A unitless composite measure of systemic inflammation calculated as the product of the absolute peripheral blood neutrophil count, monocyte count, and platelet count divided by the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
12 weeks
Change in the Composite Benefit Score (CBS)
大体时间：12 weeks
Early Parkinson's Neuro-Inflammatory Composite-15 (EPNIC-15), a composite endpoint consisting of 15 clinically relevant motor and non-motor measures derived from MDS-UPDRS Parts I, II, and III and PDSS-2 assessments. Lower scores indicate improvement in Parkinson's disease symptoms.
12 weeks
Change in MDS-UPDRS modified Part III
大体时间：12 weeks
Change from baseline in MDS-UPDRS Modified Part III score, a clinician-rated measure of Parkinson's disease motor signs assessed using a modified Part III examination. The scale evaluates motor manifestations including speech, tremor, rigidity, bradykinesia, gait, posture, and postural stability. Higher scores indicate worse motor impairment.
12 weeks
Change in MDS-UPDRS Part II scores
大体时间：12 weeks
Change from baseline in MDS-UPDRS Part II score. MDS-UPDRS Part II assesses the impact of Parkinson's disease motor symptoms on activities of daily living, with higher scores indicating greater impairment and negative changes indicating improvement.
12 weeks
Change in MDS-UPDRS Part I scores
大体时间：12 weeks
Change from baseline in MDS-UPDRS Part I score. MDS-UPDRS Part I assesses non-motor experiences of daily living in Parkinson's disease, with higher scores indicating greater symptom burden and negative changes indicating improvement.
12 weeks
Change in MDS-UPDRS combined scores
大体时间：12 weeks
Change from baseline in the combined MDS-UPDRS score (Parts I + II + III). The combined score assesses overall Parkinson's disease burden across non-motor symptoms, activities of daily living, and motor signs, with higher scores indicating greater impairment and negative changes indicating improvement.
12 weeks
Change in PDQ-39 score
大体时间：12 weeks
Change from baseline in PDQ-39 total score. The Parkinson's Disease Questionnaire-39 (PDQ-39) assesses health-related quality of life across eight domains affected by Parkinson's disease. Higher scores indicate worse quality of life and negative changes indicate improvement.
12 weeks
Clinician's General Impression of Improvement (CGI-I)
大体时间：12 weeks
Clinician's Global Impression of Improvement (CGI-I) score. The CGI-I is a clinician-rated measure of overall change in a participant's condition compared with baseline, scored on a 7-point scale from 1 (very much improved) to 7 (very much worse). Lower scores indicate greater improvement.
12 weeks
Clinician's General Impression of Severity (CGI-S)
大体时间：12 weeks
Change from baseline in Clinician's Global Impression of Severity (CGI-S) score. The CGI-S is a clinician-rated measure of overall illness severity scored on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Higher scores indicate greater severity and negative changes indicate improvement.
12 weeks
Change in PARCOMS-Motor (modified to adjust for missing MDS-UPDRS Part III scores)
大体时间：12 weeks
Change from baseline in modified PARCOMS-Motor score. PARCOMS-Motor is a composite measure of Parkinson's disease motor symptoms derived from MDS-UPDRS motor assessments. The score was modified to adjust for missing MDS-UPDRS Part III data. Higher scores indicate greater motor impairment and negative changes indicate improvement
12 weeks

其他结果措施

结果测量
措施说明
大体时间
Change in PDSS-2
大体时间：12 weeks
Change from baseline in PDSS-2 total score. The Parkinson's Disease Sleep Scale-2 (PDSS-2) assesses sleep disturbances and nocturnal symptoms associated with Parkinson's disease. Higher scores indicate worse sleep impairment and negative changes indicate improvement.
12 weeks
Change in DNA methylation
大体时间：12 weeks
Change from baseline in DNA methylation levels measured in peripheral blood samples. DNA methylation is an epigenetic biomarker associated with regulation of gene expression and cellular function.
12 weeks
Percent change in hematologic inflammatory biomarker indices
大体时间：12 weeks
Percent change from baseline in hematologic inflammatory biomarker indices (MLR, NLR, PLR, SIRI, SII, and AISI) derived from routine hematology testing. These indices are calculated from peripheral blood cell counts and are used as measures of systemic inflammation.
12 weeks
Change in plasma biomarkers of inflammation
大体时间：12 week
Change from baseline in plasma biomarkers of inflammation measured in peripheral blood samples. Plasma inflammatory biomarkers are indicators of immune and inflammatory activity that may reflect biological responses to treatment.
12 week
Interaction between baseline inflammation level and treatment effect on changes in circulating inflammatory indices
大体时间：12 weeks
Interaction between baseline inflammation level and treatment effect on changes in circulating inflammatory indices. Analysis of whether treatment effects on MLR, NLR, PLR, SIRI, SII, and AISI vary according to baseline systemic inflammation status.
12 weeks
Interaction between baseline inflammation level and treatment effect on changes in clinical endpoints
大体时间：12 weeks
Interaction between baseline inflammation level and treatment effect on changes in clinical endpoints. Analysis of whether treatment effects on clinical measures vary according to baseline systemic inflammation status.
12 weeks
Interaction between change in inflammation level and treatment effect on changes in circulating inflammatory indices
大体时间：12 week
Relationship between change in inflammation level and change from baseline in circulating inflammatory indices (MLR, NLR, PLR, SIRI, SII, and AISI). Analysis of whether treatment-related changes in systemic inflammation are associated with changes in circulating inflammatory biomarkers.
12 week
Interaction between change in inflammation level and treatment effect on changes in clinical endpoints
大体时间：12 weeks
Relationship between change in inflammation level and change from baseline in clinical endpoints. Analysis of whether treatment-related changes in systemic inflammation are associated with changes in clinical measures of Parkinson's disease.
12 weeks
Percent of subjects with any improvement from baseline as measured by CGI-I
大体时间：12 weeks
Percent of participants with improvement on CGI-I. Improvement is defined as a CGI-I score of 1 (very much improved), 2 (much improved), or 3 (minimally improved). The CGI-I is a clinician-rated measure of overall change from baseline
12 weeks
Percent of subjects with any improvement from baseline as measured by CGI-S
大体时间：12 weeks
Percent of participants with improvement in CGI-S score from baseline. Improvement is defined as any decrease from baseline in the Clinician's Global Impression of Severity (CGI-S) score. The CGI-S is a clinician-rated measure of overall illness severity scored from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Lower scores indicate less severe illness.
12 weeks
Biological and disease phenotype subgroup analyses for changes in circulating inflammatory biomarker indices
大体时间：12 weeks
Biological and disease phenotype subgroup analyses of changes in circulating inflammatory biomarker indices (MLR, NLR, PLR, SIRI, SII, and AISI). Analyses will evaluate whether treatment-related changes in inflammatory biomarkers differ across predefined biological and disease phenotype subgroups.
12 weeks
Biological and disease phenotype subgroup for changes in clinical endpoints
大体时间：12 weeks
Biological and disease phenotype subgroup analyses of changes in clinical endpoints. Analyses will evaluate whether treatment-related changes in clinical outcome measures differ across predefined biological and disease phenotype subgroups.
12 weeks

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

BioVie Inc.

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2025年3月26日

初级完成 (实际的)

2026年5月1日

研究完成 (实际的)

2026年5月31日

研究注册日期

首次提交

2024年12月24日

首先提交符合 QC 标准的

2025年1月2日

首次发布 (实际的)

2025年1月3日

研究记录更新

最后更新发布 (实际的)

2026年8月11日

上次提交的符合 QC 标准的更新

2026年8月7日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • NE3107-PD-202

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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