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临床试验/NCT07373444
NCT07373444尚未招募不适用

Westlake Aging Cohort

Westlake University2 个研究点 分布在 1 个国家目标入组 2,800 人开始时间: 2026年1月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
2,800
试验地点
2
主要终点
Cognitive function

研究概览

简要总结

The Westlake Ageing Cohort (WeAC) is a longitudinal cohort study conducted in Hangzhou, Zhejiang Province, China. The investigators aim to enroll 2,800 participants aged 55 years and older for long-term follow-up. The population will include individuals with neurodegenerative diseases or those at the prodromal stage of cognitive impairment, as well as healthy middle-aged and older adults serving as controls. The investigators will collect their sociodemographic, dietary, lifestyle, clinical, and neuroimaging data, as well as biological samples.

详细描述

The investigators will recruit middle-aged and aged participants, including healthy controls and individuals with neurodegenerative disorders such as mild cognitive impairment (MCI), Alzheimer's disease (AD), Parkinson's disease dementia (PDD), and dementia with Lewy bodies (DLB), etc. The aim of this study is to construct a longitudinal database that includes sociodemographic, lifestyle, clinical, neuroimaging, and multi-omics data. This database will be used to characterize the molecular signatures of neurodegenerative disorders. In addition, the investigators will identify biomarkers associated with neurodegenerative diseases. Furthermore, the investigators aim to uncover the mechanisms underlying the progression of mild cognitive impairment (MCI) and other neurodegenerative 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
55 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 55 and 90 years (inclusive) at baseline.
  • Availability of a companion capable of providing independent functional assessments and fluent in Chinese.
  • Willingness and ability to regularly complete required surveys and physical examinations as per study protocol.
  • MMSE scores were required to be 24-30 (inclusive) for healthy controls and MCI; and 20-24 (inclusive) for AD and DLB/PDD patients.
  • Healthy controls: CDR = 0, memory box =
  • MCI: CDR = 0.5, memory box ≥ 0.
  • AD: CDR = 0.5 or
  • The DLB/PDD meets the core features of diagnosis.
  • Healthy controls exhibit no significant cognitive or functional decline. Patients with MCI have objective cognitive impairment not sufficient for an AD diagnosis. AD patients fulfill the NINCDS-ADRDA criteria. DLB/PDD patients meet their respective international consensus diagnostic criteria. Other neurodegenerative diseases meet the diagnostic criteria.

排除标准

  • Participants with major medical or neuropsychiatric conditions unrelated to the study purposes were excluded. These included, but were not limited to, psychiatric disorders, cancer, infectious diseases, structural brain abnormalities, and epilepsy.
  • Current use of psychoactive medications or any other drugs that may affect the study.
  • Participants with cardiac pacemakers, artificial heart valves, or metallic implants in the eyes, skin, or any other part of the body.
  • Participants with any other diseases that may affect the study.

结局指标

主要结局

Cognitive function

时间窗: 48 months

Cognitive function will be evaluated using the Mini-Mental State Examination (MMSE, score range: 0-30, with higher scores indicating better cognitive function) and clinical diagnosis provided by physicians.

Gut microbiome

时间窗: 48 months

The gut microbiome will be profiled by metagenomic sequencing or ITS rRNA sequencing. In addition, fecal microbiota will be cultured, isolated, and identified.

次要结局

  • Brain magnetic resonance imaging(48 months)
  • Positron emission tomography(48 months)
  • Brain images relevant inspections(48 months)
  • Electroencephalogram(48 months)
  • Blood biochemical parameters(48 months)
  • Serum inflammatory factors(48 months)
  • Health and behavior monitoring(48 months)
  • Sleep data measurement(48 months)
  • Continuous glucose monitoring(48 months)
  • Environmental measurement(48 months)
  • Multi-omics data(48 months)

研究者

发起方
Westlake University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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