跳至主要内容
临床试验/NCT04509271
NCT04509271Unknown不适用

Shanghai Mental Health Center

Shanghai Mental Health Center1 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,300
试验地点
1
主要终点
The diagnostic accuracy of biomarkers for MCI due to AD and other dementia.

研究概览

简要总结

The prevalence of Mild Cognitive Impairment (MCI) is about 15%-17%. 10%-15% of MCI progresses to Alzheimer's disease (AD) every year. The annual incidence of MCI in the normal elderly is about 1%. Peripheral Blood biomarkers is the key and difficult points in AD research. Except expensive brain β amyloid plaque imaging, few breakthroughs of early diagnosis technology of MCI due to AD can be made to facilitate clinical application. Even Tau-181 and Tau-217 were reported in this year on Lancet neurology and JAMA. We also need to study on the biomarkers upstream of pathological changes about senile plaque. The purpose of this program is to study the reliability and validity of plasma miRNAs for early diagnosis of MCI due to AD and other dementia such as DLB and FTLD. The clinical diagnosis of AD and MCI due to AD are according to the National Institute of Aging and the Alzheimer's Disease Association (NIA-AA) diagnostic criteria in 2011. Plaque imaging is used to be golden criteria for the diagnosis of AD and MCI due to AD.

研究设计

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

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 2011 NIA-AA criteria of MCI due to AD or AD or - 2017 Diagnosis and management of dementia with Lewy bodies: Fourth consensus report of the DLB Consortium or - 2001 the McKhann consensus clinical criteria for FTD (McKhann et al.)

排除标准

  • Dementia caused by infection or substance
  • Thyroid disease

结局指标

主要结局

The diagnostic accuracy of biomarkers for MCI due to AD and other dementia.

时间窗: 1 and half years

MicRNAs battery for diagnostic of MCI due to AD

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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