Dementia of Alzheimer TypeHUNT4ADNCT06719453
Prevalence of Alzheimer's Disease Pathology in the Community
An observational study of Dementia of Alzheimer Type and Alzheimer Disease, run by Helse Stavanger HF.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia of Alzheimer Type, Alzheimer Disease, Mild Cognitive Impairment
- How many people
- 9,663 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2006to 21 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
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+.
Who may be able to join
- 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
Who cannot join
- None
About this study
Official title: Prevalence of Alzheimer's Disease Pathology in a Large Norwegian Population-based Cohort and Predictive Power of Plasma p-tau217 and NfL.
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:
Read more
- 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).
- 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
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Biomarker concentration was measured in plasma samples from three time points: In the year 2006-2008, year 2017-2019 and year 2021-2023.
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
Measured: Cognitive examination and blood sampling was conducted at two time points: In the year 2017-2019 and year 2021-2023.
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.
Measured: 14 years
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: Plasma p-tau217 was measured in plasma samples at three time points: In the year 2006-2008, year 2017-2019 and year 2021-2023.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2024
- Study start3 Oct 2006
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dementia of Alzheimer TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 9,663 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719453
- Sponsor's protocol ID
- 3870
- Acronym
- HUNT4AD
- Status last verified
- Jun 2024
- First submitted
- 4 Nov 2024
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All researchers can apply for data at the HUNT research data senter.
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Alzheimer's Disease Pathology in a Large Norwegian Population-based Cohort and Predictive Power of Plasma p-tau217 and NfL.
- ClinicalTrials.gov ID
- NCT06719453
- Acronym / sponsor ID
- HUNT4AD / 3870
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9,663 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- Göteborg University, Norwegian University of Science and Technology
- Study start
- 3 Oct 2006 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 5 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- 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+.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma p-tau217 and NfL concentrations in the HUNT4 70+ cohort, HUNT4 AiT cohort and in selected participants from HUNT3
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.
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
Time frame: 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
Time frame: 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.
2 secondary outcomes
Association between kidney function and plasma p-tau217
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))
Prevalence of amyloid pathology in different ApoE ε genotype groups
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Derived from this study: PubMed 41407852Aarsland 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.
- Individual participant dataSharing planned: Undecided. All researchers can apply for data at the HUNT research data senter.
Related trials for Dementia of Alzheimer Type
RecruitingPhase 2
A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease
Dementia, Alzheimer's Type, Alzheimer's Disease
Active, not recruiting
Effectiveness of Strength-based Intervention for Elderly With Dementia Living in the Community
Dementia, Mild Cognitive Impairment
RecruitingObservational study
Activation Sarcoma: PROMIS and Mobility Evaluation in Sarcoma Patients
Sarcoma, Giant Cell Tumor of Bone
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruitingPhase 2/3
Effect of 10 mg Xanamem on Dementia Due to Alzheimer's Disease
Dementia Moderate, Dementia, Mild
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia of Alzheimer Type and Alzheimer Disease, run by Helse Stavanger HF.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma p-tau217 and NfL concentrations in the HUNT4 70+ cohort, HUNT4 AiT cohort and in selected participants from HUNT3 (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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06719453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.