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Prevalence of Alzheimer's Disease Pathology in the Community

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06719453
Acronym
HUNT4AD
Enrollment
9663
Registered
2024-12-05
Start date
2006-10-03
Completion date
2024-10-21
Last updated
2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Biomarker in Early Diagnosis, Dementia of Alzheimer Type, Mild Cognitive Impairment, Pathology

Keywords

Blood-based markers, Population-based, p-tau217, cross-sectional, longitudinal, NfL, Alzheimer's disease pathology

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).

Interventions

None listed

Sponsors

Göteborg University
CollaboratorOTHER
Norwegian University of Science and Technology
CollaboratorOTHER
Helse Stavanger HF
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma p-tau217 and NfL concentrations in the HUNT4 70+ cohort, HUNT4 AiT cohort and in selected participants from HUNT3Biomarker 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 statusCognitive 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 NfL14 yearsReliability 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.

Secondary

MeasureTime frameDescription
Association between kidney function and plasma p-tau217Cross-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))What is the association between eGFR and plasma p-tau217 concentration in a large population-based cohort of older adults.
Prevalence of amyloid pathology in different ApoE ε genotype groupsPlasma p-tau217 was measured in plasma samples at three time points: In the year 2006-2008, year 2017-2019 and year 2021-2023.Proportion of study participants in HUNT4 70+ and HUNT4 AiT with amyloid pathology according to plasma p-tau217 in different ApoE ε genotype groups. Proportion of participants with amyloid pathology according to plasma p-tau217 among selected study participants in HUNT3 aged 60 to 69 years at study participation, differentiated by ApoE ε genotype groups. ApoE ε genotype status in participants has already been previously established.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026