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临床试验/NCT03037463
NCT03037463已完成不适用

Identification of Tear Biomarkers for Parkinson's Disease Patients

University of Southern California1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
205
试验地点
1
主要终点
Tear protein composition to discriminate between participants with Parkinson's disease and healthy controls

研究概览

简要总结

The purpose of this study is to assess whether tear secretion in patients with Parkinson's disease will be altered to exhibit a characteristic or diagnostic biomarker profile, that will be reflected in changes in the protein composition of tear fluid, which can be measured relatively easily, cost-effectively, and non-invasively. Tear fluid samples will be collected from Parkinson's patients, and through biochemical assays, the profile of proteins in tears will be characterized and compared to that from control subjects. The profiles will be analyzed with respect to any differences between Parkinson's patients and control subjects. If differences appear, the levels of these potential biomarkers in Parkinson's patients will be compared to the severity of their disease.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • established Parkinson's Disease for at least 6 months
  • Healthy controls without neurological illness

排除标准

  • currently taking anti-cholinergic medication
  • have an exposure to neuroleptic medications other than Quetiapine or Clozapine in the 6 months prior to screening
  • have an active eye infection or have had eye surgery within 3 months prior to screening
  • control subjects will be excluded if they have a history of neurological disease
  • PD subjects will be excluded if they have an atypical Parkinsonian syndrome

结局指标

主要结局

Tear protein composition to discriminate between participants with Parkinson's disease and healthy controls

时间窗: up to 12 months

4 potential biomarkers will be evaluated in collected tear fluid and will be followed longitudinally for 3-4 visits

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Hamm-Alvarez

Professor and Vice Chair, Basic Research; Associate Dean, Basic and Translational Research; Director, Research development

University of Southern California

研究点 (1)

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