DementiaNCT04786561
Depression, Anxiety and Social Relationships as Risk Factors for Dementia
An observational study of Dementia and Dementia Alzheimers, run by Norwegian Centre for Ageing and Health at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Dementia Alzheimers, Risk Factor
- How many people
- 11,000 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2020to 1 Jan 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: Inhabitants living in the designated areas that voluntared to the health survey and accepted a cognitive test.
Who may be able to join
- Living in designated area
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Depression as Risk Factor for Dementia
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.
Read the detailed description
The Health Study in Nord-Trondelag (HUNT) fulfils most of the key requirements of a population-representative cohort study by meeting the following elements: firm knowledge about the population denominator, knowledge about reasons for refusal (in line with previous methods in HUNT), options for levels and localisation of participation (at test station, at home, at nursing homes), coverage of sociodemographic features by the comprehensive HUNT4-protocol and register linkage, inclusion of institutionalized individuals and individuals with reduced capacity to consent, measurement of risk and compensatory factors across the life course by merging with previous results in HUNT surveys and linkage to registries, core elements and assessment methods can be compared with other European populations studies including elderly people, and finally, the ability to include biobank results in the data analysis. The HUNT data supplemented by register linkage include all established and suspected risk factors of dementia.
A particular focus on primary health care is appropriate because it is in this part of the health care system that the need for extra resources due to the substantial increase in dementia prevalence is most pronounced. Furthermore, preventive measures in a life-course perspective will mainly have to be implemented in the primary health care setting.
- Conditions
- Dementia, Dementia Alzheimers, Risk Factor, Depression, Anxiety, Social Isolation
- Medical subject headings
- Dementia, Alzheimer Disease, Depression, Anxiety Disorders, Social Isolation
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 |
|---|---|---|
| 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+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2017-2019
Secondary outcomes (1)
Change in loneliness
Self-reported feeling of loneliness
Measured: 1995-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Jan 2020
- Primary completion1 Jan 2024
- Study completion1 Jan 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 DementiaStudies 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
- Retrospective
- Enrolment
- 11,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Centre for Ageing and Health
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Health Association, Norwegian University of Science and Technology, Norwegian Institute of Public Health, University College, London
- Responsible party
- Sponsor
- Investigators
- Geir Selbæk, Phd, Principal investigator, Norwegian National Advisory Unit on Ageing and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786561
- Sponsor's protocol ID
- 181011
- Status last verified
- Mar 2024
- First submitted
- 6 Feb 2020
- Last updated
- 22 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40735047
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression as Risk Factor for Dementia
- ClinicalTrials.gov ID
- NCT04786561
- Acronym / sponsor ID
- 181011
- Conditions
- Dementia, Dementia Alzheimers, Risk Factor, Depression, Anxiety, Social Isolation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,000 participants (actual)
- Lead sponsor
- Norwegian Centre for Ageing and HealthUniversity, hospital or other
- Collaborators
- Norwegian Health Association, Norwegian University of Science and Technology, Norwegian Institute of Public Health, University College, London
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 8 Mar 2021 (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 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.
Detailed description
The Health Study in Nord-Trondelag (HUNT) fulfils most of the key requirements of a population-representative cohort study by meeting the following elements: firm knowledge about the population denominator, knowledge about reasons for refusal (in line with previous methods in HUNT), options for levels and localisation of participation (at test station, at home, at nursing homes), coverage of sociodemographic features by the comprehensive HUNT4-protocol and register linkage, inclusion of institutionalized individuals and individuals with reduced capacity to consent, measurement of risk and compensatory factors across the life course by merging with previous results in HUNT surveys and linkage to registries, core elements and assessment methods can be compared with other European populations studies including elderly people, and finally, the ability to include biobank results in the data analysis. The HUNT data supplemented by register linkage include all established and suspected risk factors of dementia.
A particular focus on primary health care is appropriate because it is in this part of the health care system that the need for extra resources due to the substantial increase in dementia prevalence is most pronounced. Furthermore, preventive measures in a life-course perspective will mainly have to be implemented in the primary health care setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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+ |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Inhabitants living in the designated areas that voluntared to the health survey and accepted a cognitive test.
Key inclusion criteria (1 listed)
- Living in designated area
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
Incidence of dementia diagnosis in HUNT4 70+ study
Time frame: 2017-2019
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.
Incidence of Minimal Cognitive Impairment (MCI) in the HUNT 70+ study
Time frame: 2017-2019
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.
1 secondary outcome
Change in loneliness
Time frame: 1995-2019
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 22 Mar 2024.
- Derived from this study: PubMed 40735047Aunsmo 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.
- Individual participant dataSharing planned: No
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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.
Geir Selbæk, Phd principal investigator
Norwegian National Advisory Unit on Ageing and Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Dementia Alzheimers, run by Norwegian Centre for Ageing and Health at 1 site in Norway.
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 1 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 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Incidence of dementia diagnosis in HUNT4 70+ study (time frame: 2017-2019). The study lists 2 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 NCT04786561, 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 22 Mar 2024.