Clinical trial NCT06719453: Prevalence of Alzheimer's Disease Pathology in the Community
Official title: Prevalence of Alzheimer's Disease Pathology in a Large Norwegian Population-based Cohort and Predictive Power of Plasma p-tau217 and NfL.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia of Alzheimer Type
Alzheimer Disease
Mild Cognitive Impairment
Pathology
Biomarker in Early Diagnosis
Keywords: Blood-based markers
Population-based
p-tau217
cross-sectional
longitudinal
NfL
Alzheimer's disease pathology
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
Collaborators: name: Göteborg University
name: Norwegian University of Science and Technology
First posted: 2024-12-05
Enrollment: 9663
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The Nord-Trøndelag Health Study (HUNT) is carried out in the geographically defined area of Nord-Trøndelag i Norway and offers a good representation of the Norwegian population.

The HUNT study has invited the adult population in the area to participate in four waves: HUNT1 (1984 - 1986), HUNT2 (1995-1997), HUNT3 (2006 - 2008) and HUNT4 (2017 - 2019). HUNT4 70+ also included a follow-up, Ageing in Trøndelag (AiT) (2021 - 2023). Notably, the HUNT4 study recruited all people 70 + years of age from HUNT4 to participate in the study, HUNT4 70+.

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Plasma p-tau217 and NfL concentrations in the HUNT4 70+ cohort, HUNT4 AiT cohort and in selected participants from HUNT3
timeFrame: Biomarker concentration was measured in plasma samples from three time points: In the year 2006-2008, year 2017-2019 and year 2021-2023.
measure: Association between concentrations of plasma p-tau217 and NfL with cognitive status
timeFrame: Cognitive examination and blood sampling was conducted at two time points: In the year 2017-2019 and year 2021-2023.
measure: Predictive power of plasma p-tau217 and NfL
timeFrame: 14 years
Secondary outcomes:
measure: Association between kidney function and plasma p-tau217
timeFrame: 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))
measure: Prevalence of amyloid pathology in different ApoE ε genotype groups
timeFrame: Plasma p-tau217 was measured in plasma samples at three time points: In the year 2006-2008, year 2017-2019 and year 2021-2023.
Other outcomes:
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