跳至主要内容
临床试验/NCT04360200
NCT04360200招募中不适用

Cognitive Impairment in Ageing People: A Longitudinal Observational Prospective Study

Yamei Tang1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
5,000
试验地点
1
主要终点
Incidence of Dementia

研究概览

简要总结

Mild cognitive impairment (MCI) and neurocognitive disorder such as Alzheimer's disease (AD) and Vascular dementia (VaD) have become common diseases in the elderly. The burden of dementia is rising in China, with major medical, social and economic impacts. To address this important public health problem, cohort study on elderly cognitive disorders should be carry out. The methods of early prevention, early diagnosis and early treatment the cognitive disorders in elderly should be found to reduce the burden of the social and economic issue due to dementia. At present, the international corresponding guidelines have taken gene and brain imaging biomarkers as important indicators of dementia pathogenesis research, accurate diagnosis and targeted intervention. The study will construct a prospective cohort to establish database that provide not only comprehensive epidemiological data on the MCI and neurocognitive disorder in ageing people, but also complete the construction of biological samples bank and clinical diagnosis and treatment information database. Using the database, the study will identify the conversion rates from MCI to dementia and risk factors for the progression from MCI to dementia or AD. The study will also apply and develop brain structural and pathological imaging technology to support precision diagnosis of senile cognitive disorders. The study have goals to identify and validate imaging and blood/CSF biomarkers for the early detection and tracking of cognitive disorders.

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

入选标准

  • Patients over 50 years old.
  • Sign informed consent.
  • According to DSM-IV, the diagnostic standard of dementia was not met.
  • The clinical dementia rating (CDR) was 0.
  • Exclusion criteria:
  • Subjects with mental retardation.
  • Refuse to have blood sampling, imaging and other examinations.
  • Uncooperative subjects that have serious organic diseases, or have a history of mental illness, or have physical disability (including severe aphasia).
  • Contraindications of MR scanning.
  • Suffering from serious physical or mental illness.

排除标准

  • 未提供

结局指标

主要结局

Incidence of Dementia

时间窗: April 2020 to December 2040

次要结局

  • The conversion rate of normal elderly to MCI to neurocognitive disorder(April 2020 to December 2040)
  • Improvement of Cognitive Function based on Montreal Cognitive Assessment (MoCA) score(April 2020 to December 2040)

研究者

发起方
Yamei Tang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yamei Tang

Professor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

研究点 (1)

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