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临床试验/NCT03447613
NCT03447613已完成不适用

Association of Retinal Nerve Fiber Layer (RNFL) Thickness With Cerebrospinal Fluid Aβ and Tau Concentration

Shanghai 10th People's Hospital1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2013年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
86
试验地点
1
主要终点
Specific cognitive function

研究概览

简要总结

To test the hypothesis that retinal nerve fiber layer (RNFL) thickness is correlated with Aβ and Tau concentration of cerebrospinal fluid (CSF) in an older population.

详细描述

retinal nerve fiber layer (RNFL) thickness changing has been reported in Alzheimer's Disease (AD) patients at an early stage, and has been demonstrated as a potential biomarker able to predict cognitive deterioration (Hinton DR et al., N Engl J Med 1986; London A et al. Nat Rev Neurol 2013; Chang LY et al., Alzheimers Dement 2014). However, whether RNFL thickness is correlated with cerebrospinal fluid (CSF) features of AD pathogenesis (e.g., Aβ and Tau) remains unclear. The investigators thus conducted this observational cohort study to test the correlation between RNFL thickness changing and CSF, to further validate RNFL as a potential AD biomarker.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • 50 years old or older;
  • five years or more of education and scores of MMSE ≥ 24 points;
  • Chinese as their first language;
  • Having spinal anesthesia.

排除标准

  • prior diagnoses of neurologic diseases, e.g., dementia, Parkinson's diseases, multiple sclerosis or stroke according to DSM-IV;
  • history of mental disorders (e.g., major depressive disorder and schizophrenia) diagnosed according to DSM-IV;
  • known diseases contributing to the retina pathologies, e.g., diabetes, glaucoma or increased intraocular pressure (more than 22 mmHg), cataract, and macular degeneration and hypermyopia;
  • unwillingness to comply with the cognitive assessments;
  • ungradable images of OCT.

结局指标

主要结局

Specific cognitive function

时间窗: Within one week before surgery

Neuropsychological test battery to assess specific cognitive function, including immediate memory, visuospatial memory and executive function.

次要结局

  • retinal nerve fiber layer (RNFL) thickness(Within one week before surgery)
  • Cerebrospinal fluid (CSF) Aβ concentration(During the spinal anesthesia before the administration of the local anesthetic.)
  • Cerebrospinal fluid (CSF) Tau concentration(During the spinal anesthesia before the administration of the local anesthetic.)
  • Global cognitive state(Within one week before surgery)

研究者

发起方
Shanghai 10th People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yuan Shen, MD, PhD

Chief of Psychiatry Department

Shanghai 10th People's Hospital

研究点 (1)

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