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Prospective Multicenter Registry Study of Multiple System Atrophy in China (MSA Registry S)

2026年6月8日 更新者:Peking University First Hospital

Clinical Features and Natural History of Multiple System Atrophy: A Prospective Multicenter Registry Study in China

Multiple system atrophy is a rare, rapidly progressive neurodegenerative disease characterized by variable combinations of parkinsonism, cerebellar ataxia, and autonomic dysfunction. Existing natural history studies from North America, Europe, and Japan suggest that clinical phenotypes and disease progression may differ across populations. However, comprehensive multicenter prospective data from Chinese patients with multiple system atrophy remain limited.

This prospective multicenter registry study aims to describe the clinical characteristics, longitudinal progression, and outcomes of Chinese patients with multiple system atrophy, to identify factors associated with disease progression and prognosis, and to establish a longitudinal cohort for future biomarker validation and clinical trial design.

研究概览

详细说明

Multiple system atrophy is an adult-onset, progressive neurodegenerative disorder characterized by parkinsonism, cerebellar ataxia, autonomic dysfunction, and variable non-motor manifestations. The disease is pathologically associated with alpha-synuclein accumulation and neuronal and glial degeneration in multiple brain regions. Due to its rarity, clinical heterogeneity, rapid progression, and poor prognosis, large-scale prospective studies are needed to better define its natural history and to support future therapeutic development.

This study is a prospective, observational, multicenter registry study conducted in China. Eligible participants will include patients with clinically established or clinically probable multiple system atrophy according to the 2022 Movement Disorder Society diagnostic criteria. Parkinson disease patients and healthy or non-neurodegenerative controls may also be enrolled for comparative analyses.

Data will be collected through in-person visits, medical record review, standardized clinical scales, neurological examinations, autonomic function testing, neuroimaging, laboratory tests, and biospecimen collection. Longitudinal follow-up will be performed at prespecified time points, including alternating in-person and telephone-based assessments when applicable. Clinical scales may include the Unified Multiple System Atrophy Rating Scale, Movement Disorder Society-sponsored Unified Parkinson's Disease Rating Scale, non-motor symptom scales, autonomic symptom scales, and disability measures. Neuroimaging, autonomic function tests, electrophysiological or oculomotor evaluations, and biospecimen-based analyses may be performed according to the study protocol and local clinical practice.

The main objectives are to characterize the clinical features and longitudinal disease course of Chinese patients with multiple system atrophy, compare clinical characteristics between MSA-P and MSA-C subtypes, identify clinical and paraclinical factors associated with disease progression and prognosis, and establish a longitudinal platform for subsequent biomarker validation and clinical trial design.

研究类型

观察性的

注册 (估计的)

214

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。

学习联系方式

学习地点

    • Beijing Municipality
      • Beijing、Beijing Municipality、中国、100034
        • 招聘中
        • Peking University First Hospital
        • 接触:

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

是的

取样方法

非概率样本

研究人群

Patients with MSA or PD who visited the outpatient department or wards of tertiary hospitals. Those who voluntarily participated, along with the family members of healthy individuals without neurodegenerative diseases, served as healthy controls.

描述

Inclusion Criteria

  1. Patients with clinically established or clinically probable multiple system atrophy according to the 2022 Movement Disorder Society diagnostic criteria; or
  2. Patients with clinically established or clinically probable Parkinson disease according to the Movement Disorder Society diagnostic criteria; or
  3. Healthy controls or controls without hereditary or neurodegenerative diseases who voluntarily agree to participate.
  4. Age between 40 and 75 years.
  5. Ability to provide informed consent or availability of a legally authorized representative when applicable.

Exclusion Criteria

  1. Parkinsonism that cannot be classified as Parkinson disease or multiple system atrophy at the time of evaluation.
  2. Clinical suspicion or diagnosis of other atypical parkinsonian syndromes, including progressive supranuclear palsy, dementia with Lewy bodies, or corticobasal syndrome.
  3. Secondary parkinsonism due to intracranial space-occupying lesions, normal pressure hydrocephalus, drug-induced parkinsonism, or other identifiable causes.
  4. Comorbid diseases that may substantially affect autonomic function, such as diabetic peripheral neuropathy or amyloidosis.
  5. Refusal to participate in the study or refusal to undergo routine clinical evaluations for parkinsonian syndromes.
  6. Psychiatric or behavioral abnormalities that preclude reliable clinical data collection or scale-based assessment.

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

队列和干预

团体/队列
MSA
PD
HC
Healthy control / Control without neurodegenerative diseases

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
Change in disease severity
大体时间:Baseline to up to 36 months after enrollment.
Change in disease severity as measured by the Unified Multiple System Atrophy Rating Scale over longitudinal follow-up.
Baseline to up to 36 months after enrollment.

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。

调查人员

  • 首席研究员:Zhaoxia Wang, MD、Department of Neurology, Peking University First Hospital

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6月1日

初级完成 (估计的)

2029年12月31日

研究完成 (估计的)

2030年6月30日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年6月12日

上次提交的符合 QC 标准的更新

2026年6月8日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

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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