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临床试验/NCT06719453
NCT06719453已完成不适用

Prevalence of Alzheimer's Disease Pathology in a Large Norwegian Population-based Cohort and Predictive Power of Plasma p-tau217 and NfL.

Helse Stavanger HF0 个研究点目标入组 9,663 人开始时间: 2006年10月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
9,663
主要终点
Plasma p-tau217 and NfL concentrations in the HUNT4 70+ cohort, HUNT4 AiT cohort and in selected participants from HUNT3

研究概览

简要总结

The goal of this observational study is to (I) study the proportion of people with Alzheimer's disease pathology in a large Norwegian population-based cohort of people aged 70 years or older and to (II) study longitudinal changes of Alzheimer's disease pathology in the same population over a 14 year period.

The main aims are:

  • What is the proportion of people with Alzheimer's disease pathology, defined by elevated plasma p-tau217, in a large Norwegian population-based cohort of people aged 70 years or older.
  • What is the proportion of people with Alzheimer's disease pathology, defined by elevated plasma p-tau217, among those with normal cognition, mild cognitive impairment and dementia in a large Norwegian population-based cohort of people aged 70 years or older.
  • What is the association between plasma p-tau217 concentration and mild cognitive impairment or dementia 4, 10 and 14 years later, respectively.
  • What is the association between plasma NfL concentration and mild cognitive impairment or dementia 4, 10 and 14 years later, respectively.

Data is used from The Nord-Trøndelag Health Study (HUNT) wave 3 (2006-2008) and 4 (2017 - 2019, also including HUNT AiT 2021-2023).

研究设计

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

入排标准

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

入选标准

  • Living in the area of Nord-Trøndelag, where the HUNT study is carried out.
  • Age 70 or older when participating in HUNT4
  • Available blood sample from HUNT3, HUNT4 70+ or HUNT4 70+ AiT

排除标准

  • 未提供

结局指标

主要结局

Plasma p-tau217 and NfL concentrations in the HUNT4 70+ cohort, HUNT4 AiT cohort and in selected participants from HUNT3

时间窗: Biomarker concentration was measured in plasma samples from three time points: In the year 2006-2008, year 2017-2019 and year 2021-2023.

Concentration of plasma p-tau217 measured by Alzpath217 and plasma NfL measured by Neurology 4-plex E kit. For p-tau217, we will administer a cut-off previously derived from the Wisconsin Registry for Alzheimer's Prevention study to define particpants as amyloid positive, amyloid negative or in an intermediate range.

Association between concentrations of plasma p-tau217 and NfL with cognitive status

时间窗: Cognitive examination and blood sampling was conducted at two time points: In the year 2017-2019 and year 2021-2023.

Association between concentrations of plasma p-tau217 and NfL with a clinical diagnosis of normal cognition, MCI and dementia in the HUNT4 70+ cohort and the HUNT4 AiT cohort

Predictive power of plasma p-tau217 and NfL

时间窗: 14 years

Reliability of plasma p-tau217 and NfL concentrations in HUNT3 and HUNT4 70+ for predicting cognitive impairment (I) measured by the MOCA in HUNT4 70+ and HUNT AiT, (II) defined by a clinical diagnosis of mild cognitive impairment or dementia in HUNT4 70+ and HUNT AiT.

次要结局

  • Association between kidney function and plasma p-tau217(Cross-sectional measurements at three time points: In the year 2006-2008, year 2017-2019 and year 2021-2023. And longitudinal analysis (14 years, from 2006-2008 to 2021-2023)))
  • Prevalence of amyloid pathology in different ApoE ε genotype groups(Plasma p-tau217 was measured in plasma samples at three time points: In the year 2006-2008, year 2017-2019 and year 2021-2023.)

研究者

申办方类型
Other Gov
责任方
Sponsor

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