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临床试验/NCT04804618
NCT04804618招募中不适用

Exploring Research on Early Warning Indicators of Protein in Patients With Mild Cognitive Impairment and Alzheimer's Disease

Guangzhou University of Traditional Chinese Medicine1 个研究点 分布在 1 个国家目标入组 650 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
650
试验地点
1
主要终点
Changes in the protein expression profile of urine and saliva

研究概览

简要总结

This study intends to adopt standardized and rigorous cross-sectional research, collect biological specimens (including blood, feces, urine, saliva and tongue coating) from eligible subjects, and use liquid chromatography/mass spectrometry (LC-MS/MS) technology to explore early warning indicators of protein in patients with mild cognitive impairment and Alzheimer's disease

详细描述

The problem of population aging is getting worse, the prevalence of senile dementia is increasing, and Alzheimer's disease (AD) is the most common type of dementia. There is no effective treatment for AD. Most interventions can only alleviate the condition and delay the development. Therefore, early diagnosis and prevention of AD are extremely important. However, the current diagnostic measures are not suitable for clinical promotion due to their traumatic nature, so there is an urgent need for a more suitable clinical early identification and diagnosis method. Proteomics research technology is the leading research technology in China. It can be applied to research on disease markers, pathogenesis, and drug target discovery.

Therefore, this study intends to adopt standardized and rigorous cross-sectional research, collect biological specimens (including blood, feces, urine, saliva and tongue coating) from eligible subjects, and use liquid chromatography/mass spectrometry (LC-MS/MS) technology to explore early warning indicators of protein in patients with mild cognitive impairment and Alzheimer's disease

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Older than 55-year-old,male or female.
  • patients meet the diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease(AD) or whose family members were diagnoed with AD
  • Complete self-rating scale for memory impairment (AD-8 scale)
  • Those who agree to participate in clinical research and sign informed consent.

排除标准

  • Patients with acute cardiovascular and cerebrovascular diseases, acute infections (pneumonia, urinary tract infection, oral infection, digestive tract infection), severe renal dysfunction, and uremia;
  • Pregnant or lactating women;

结局指标

主要结局

Changes in the protein expression profile of urine and saliva

时间窗: An Average of 1 year

Proteomic expression of urine and saliva in each group will be tested use Protein liquid chromatography/mass spectrometry detection.

次要结局

  • Change of the cognitive function every year(An Average of 1 year)
  • Changes in plasma protein expression profile every year(An Average of 1 year)
  • Variation characteristics of gut microbiome every year(An Average of 1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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