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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04786561
Other study ID # 181011
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date January 1, 2024

Study information

Verified date March 2024
Source Norwegian Centre for Ageing and Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 11000
Est. completion date January 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria: - Living in designated area Exclusion Criteria: - None

Study Design


Locations

Country Name City State
Norway Norwegian national advisory unit on Ageing and Health Tønsberg

Sponsors (5)

Lead Sponsor Collaborator
Norwegian Centre for Ageing and Health Norwegian Health Association, Norwegian Institute of Public Health, Norwegian University of Science and Technology, University College, London

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Change in loneliness Self-reported feeling of loneliness 1995-2019
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