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{"title":"Disease-Modifying Trials in Treated Parkinson's Disease: \"Stable Treated\" Does Not Equate with Biological Stability.","authors":"M Maral Mouradian,A Jon Stoessl,Anthony E Lang","doi":"10.1002/mds.30259","DOIUrl":null,"url":null,"abstract":"Traditionally, clinical trials of putative disease-modifying therapies in Parkinson's disease have enrolled untreated patients at the earliest clinical stages of their disease. Due to a number of challenges inherent with this approach, there has been a recent move to a different study design, enrolling patients who are already taking \"stable\" anti-parkinson medication. However, typically, the symptomatic treatment regimen has not been defined uniformly with respect to drugs and dosages utilized or duration of therapy. More importantly, this approach fails to consider or account for the major pharmacodynamic changes induced in the parkinsonian brain by varying dopaminergic therapies (particularly levodopa) and the impact of these on both clinical and neuroimaging outcome measures. In this review, we highlight what is known about the changes induced by dopaminergic therapy and the challenges these will present in the interpretation of outcomes of studies using this trial design. © 2025 The Author(s). Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.","PeriodicalId":213,"journal":{"name":"Movement Disorders","volume":"21 1","pages":""},"PeriodicalIF":7.6000,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Movement Disorders","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/mds.30259","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}
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治疗帕金森病的疾病改善试验:“稳定治疗”并不等同于生物稳定性。
传统上,帕金森病推定的疾病改善疗法的临床试验在其疾病的早期临床阶段招募了未经治疗的患者。由于这种方法固有的一些挑战,最近有一项不同的研究设计,招募已经服用“稳定”抗帕金森药物的患者。然而,典型的对症治疗方案在药物和使用剂量或治疗持续时间方面没有统一的定义。更重要的是,这种方法没有考虑或解释不同多巴胺能疗法(尤其是左旋多巴)在帕金森大脑中引起的主要药效学变化,以及这些对临床和神经影像学结果测量的影响。在这篇综述中,我们强调了关于多巴胺能治疗引起的变化的已知情况,以及这些变化将在使用该试验设计的研究结果的解释中提出的挑战。©2025作者。Wiley期刊有限责任公司代表国际帕金森和运动障碍学会出版的《运动障碍》。
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