Prevalence of Alzheimer's Disease Pathology in the Community

NCT06719453 | Completed

• 1 other identifier: 3870
• Study Type: observational
• Target: 9,663
• Locations: 0 countries
• Sites: N/A

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).

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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

  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.

  14 years

Secondary Outcomes (2)

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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+.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Helse Stavanger HF: lead
• Göteborg University: collaborator
• Norwegian University of Science and Technology: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Plasma

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: December 5, 2024
• Study Start: October 3, 2006
• Primary Completion: October 21, 2024
• Study Completion: October 21, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-06