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CompletedNCT06719453HUNT4ADUpdated Dec 5, 2024

Prevalence of Alzheimer's Disease Pathology in the Community

An observational study in Dementia of Alzheimer Type, Alzheimer Disease and Mild Cognitive Impairment, sponsored by Helse Stavanger HF. Completed. Open to participants aged 70 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-05.

Sponsored by Helse Stavanger HF · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
9,663
Ages
70 Years and older
Sex
All
01

Study 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).

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Conditions studied

  • 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
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In context

Alzheimer Disease

3,765 studies on the registry are indexed under Alzheimer Disease; 881 are open to participants now.

This study's enrollment of 9,663 is above the median of 200 across 780 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Helse Stavanger HF is the lead sponsor of 97 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
70 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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+.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • None
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
9,663 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • The Trøndelag Health Study (The HUNT Study)

    (I) All participants from the HUNT4 70+ cohort (conducted 2017-2019, N=9,963) who have a blood sample (N=8,949). Participants underwent cognitive evaluation. (II) Selection of 3,948 participants from the HUNT3 cohort (conducted 2006-2008, n=8,548.). Selection criteria: Later participation in the HUNT4 70+ cohort or HUNT4 70+ AiT cohort and having an available blood sample in HUNT3. The 3,948 participants were further selected to include all those with a dementia diagnosis in HUNT4 70+ (N=approx. 1,100). Of the remaining HUNT3 participants included, 1/3 should have a diagnosis of normal cognition in HUNT4 70+, and 2/3 should have a diagnosis of mild cognitive impariment in HUNT4 70+. (III) All participants from the HUNT AiT cohort (Conducted 2021-2023, N=5,710) who have a blood sample. All HUNT4 70+ participants were invited to participate in HUNT4 AiT 4 years later. Participants underwent cognitive evaluation.

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What researchers measure

Primary outcomes

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

    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.

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

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

    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

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

  3. Predictive power of plasma p-tau217 and NfL

    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.

    Time frame: 14 years

Secondary outcomes

  1. Association between kidney function and plasma p-tau217

    What is the association between eGFR and plasma p-tau217 concentration in a large population-based cohort of older adults.

    Time frame: 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))

  2. Prevalence of amyloid pathology in different ApoE ε genotype groups

    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.

    Time frame: Plasma p-tau217 was measured in plasma samples at three time points: In the year 2006-2008, year 2017-2019 and year 2021-2023.

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Aarsland D, Sunde AL, Tovar-Rios DA, Leuzy A, Fladby T, Zetterberg H, Blennow K, Tan K, De Santis G, Yakoub Y, Arslan B, Huber H, Pola I, Grotschel L, Di Molfetta G, Skjellegrind HK, Selbaek G, Ashton NJ. Prevalence of Alzheimer's disease pathology in the community. Nature. 2026 Feb;650(8100):182-186. doi: 10.1038/s41586-025-09841-y. Epub 2025 Dec 17. PubMed 41407852 ↗

Individual participant data

Plan to share: Undecided — All researchers can apply for data at the HUNT research data senter.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06719453
Lead sponsor
Helse Stavanger HF
Responsible party
Sponsor
First posted
Dec 5, 2024
Start date
Oct 3, 2006
Primary completion
Oct 21, 2024
Completion
Oct 21, 2024
Last update
Dec 5, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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