Dementia Clinical Trial
Official title:
Modifiable Risk Factors and Dementia - A Study Examining the Association Between Hearing Impairment in Mid-life and Cognitive Impairment in the HUNT4 70+ Study
NCT number | NCT04284384 |
Other study ID # | 181009 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 19, 2019 |
Est. completion date | November 20, 2020 |
Verified date | September 2021 |
Source | Norwegian Centre for Ageing and Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This Doctor of Philosophy (PhD) project is part of a larger project on potentially modifiable risk factors for dementia in a life course perspective, with an overarching aim to improve prevention of dementia and thereby potentially relieve patient and caregiver distress and decrease societal load. The present PhD project will concentrate on confirming knowledge of HI as an independent risk factor for dementia and exploring potentially causative factors to explain this relationship.
Status | Completed |
Enrollment | 6952 |
Est. completion date | November 20, 2020 |
Est. primary completion date | November 20, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 70 Years and older |
Eligibility | Inclusion Criteria: - Living in designated area Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
Norway | Norwegian National Advisory Unit of Ageing and Health | Tønsberg |
Lead Sponsor | Collaborator |
---|---|
Norwegian Centre for Ageing and Health | Norwegian University of Science and Technology, The Nord-Trøndelag Health Study, The Norwegian Institute of Public Health, University College London Hospitals, University of Oslo |
Norway,
GjØra L, Strand BH, Bergh S, Borza T, Brækhus A, Engedal K, Johannessen A, Kvello-Alme M, Krokstad S, Livingston G, Matthews FE, Myrstad C, Skjellegrind H, Thingstad P, Aakhus E, Aam S, Selbæk G. Current and Future Prevalence Estimates of Mild Cognitive Impairment, Dementia, and Its Subtypes in a Population-Based Sample of People 70 Years and Older in Norway: The HUNT Study. J Alzheimers Dis. 2021;79(3):1213-1226. doi: 10.3233/JAD-201275. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of dementia diagnosis 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 Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5). | 2017-2019 | |
Primary | Rate 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 | |
Primary | Rate of cognitive impairment defined as age- and education-adjusted thresholds on cognitive assessments scales | The participants have been assessed with the Montreal Cognitive Assessment scale and the ten-word recall test | 2017-2019 |
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