NCT04786561

Brief Summary

The main objective of the present work is to establish a firm knowledge base regarding depression and anxiety as risk factors for dementia and how social relationships impact this association. This risk factors, and efforts to reduce them are described through a follow up over three decades.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

4 years

First QC Date

February 6, 2020

Last Update Submit

March 21, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Incidence of dementia diagnosis in HUNT4 70+ study

    Two clinical and scientific experts will independently set at diagnosis of cognitive impairment or dementia based on all available information applying standard diagnostic criteria DSM-5.

    2017-2019

  • Incidence of Minimal Cognitive Impairment (MCI) in the HUNT 70+ study

    Two clinical and scientific experts will independently set at diagnosis of cognitive impairment or dementia based on all available information applying standard diagnostic criteria DSM-5.

    2017-2019

Secondary Outcomes (1)

  • Change in loneliness

    1995-2019

Study Arms (2)

HUNT4 70+

All inhabitants of Nord-Trøndelag 70 years or older were invited to participate in HUNT 4 70+. HUNT4 refers to the fourth wave of the HUNT-study (HelseUndersøkelse i Nord-Trøndelag or health survey in northern part of Trøndelag community in Middle of Norway) and 70+ refers to the part of the survey directed to participants aged seventy years and older.

HUNT4 70+ Trondheim

All inhabitants of one district in Trondheim 70 years or older were invited to participate in HUNT 4 70+

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inhabitants living in the designated areas that voluntared to the health survey and accepted a cognitive test.

You may qualify if:

  • Living in designated area

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian national advisory unit on Ageing and Health

Tønsberg, Norway

Location

Related Publications (1)

  • Aunsmo RH, Strand BH, Bergh S, Hansen T, Kivimaki M, Kohler S, Krokstad S, Langballe EM, Livingston G, Matthews FE, Selbaek G. Loneliness trajectories and dementia risk: Insights from the HUNT cohort study. Alzheimers Dement (Amst). 2025 Jul 29;17(3):e70154. doi: 10.1002/dad2.70154. eCollection 2025 Jul-Sep.

MeSH Terms

Conditions

DementiaAlzheimer DiseaseDepressionAnxiety DisordersSocial Isolation

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesBehavioral SymptomsBehaviorSocial Behavior

Study Officials

  • Geir Selbæk, Phd

    Norwegian National Advisory Unit on Ageing and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2020

First Posted

March 8, 2021

Study Start

January 1, 2020

Primary Completion

January 1, 2024

Study Completion

January 1, 2024

Last Updated

March 22, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations