Clinical trial NCT04289389: Prevalence and Level of Diagnosis of Dementia in a Population-based Sample in the County of Trøndelag
Official title: Prevalence and Level of Diagnosis of Dementia in a Population-based Sample in the County of Trøndelag
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dementia
Keywords: Prevalence
Epidemiology
Alzheimer's disease
Lead sponsor: Norwegian Centre for Ageing and Health
Sponsor class: OTHER
Collaborators: name: Norwegian Health Association
name: University of Oslo
First posted: 2020-02-28
Enrollment: 11675
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons of 70 years of age or older participated in HUNT4 and accepted cognitive screening in HUNT4 70+.

Brief summary: To investigate and make valid estimates of the occurrence of dementia and the most common subtypes of dementia in Trøndelag, and transfer these figures to estimates of the occurrence of dementia in Norway as a whole, by age, sex and severity of dementia. Furthermore, the proportion of people without dementia diagnosis among those with dementia will be examined. The investigators will further investigate whether there are differences in dementia prevalence between males and females and educational groups and look at factors associated with a lack of diagnosis.

Detailed description: Introduction There are currently no valid estimates of the occurrence of dementia in Norway. Estimates in use range from 70.000 to 104.000, with the highest estimate being 50 percent greater than the lowest. This makes it difficult to plan today's health services and estimate future needs.

To enable good planning of services to people with dementia, it is important that people with dementia to be evaluated and diagnosed for their illness. An early diagnosis seems to improve prognosis for the course of the disease. The proportion of undiagnosed people with dementia differs in the studies done on this and it is unclear which factors that may explain why many remain undiagnosed for their dementia disease. As a quality measure on the cognitive data being collected in this study we will make population-based Norwegian norms for the Montreal Cognitive Assessment Test (MoCA) test and the Ten-word delayed recall test from CERAD.

The aim of this study is to provide knowledge that is crucial for planning good health and care services for older people with cognitive impairment and dementia. We will make valid estimates for the prevalence of dementia and the most common subtypes of them in Trøndelag and transfer these figures to estimates to Norway as a whole, by age, gender and severity of disease. We will investigate whether there are differences in dementia prevalence between males and females and educational groups. Furthermore, there will be made a survey of the proportion of people without dementia diagnosis among those with dementia, and examine the factors associated with a lack of diagnosis.

Method The data collection was a collaboration with the Health Survey in Nord-Trøndelag when this was carried out for the fourth time (HUNT4) in the period 2017-2019. All persons over the age of 70 living in 23 municipalities in Nord-Trøndelag and a district in Trondheim municipality (Trøndelag) were invited to an assessment at a field stations or by home visits (including institutionalized care), in the study parts called HUNT4 70+ and HUNT4 Trondheim 70+. The participants were offered a survey of cognition and function in everyday life. To get more information on cognitive function an interview with next of kin were made for participants with possible cognitive impairment.

A diagnostic work-up group of scientific and clinical experts (geriatrics, old age psychiatry or neurology) assessed the cases and made the research-based diagnosis. Standard diagnostic criteria according to the DSM-5 was applied for all the dementia diseases. The new estimates from Trøndelag will be used to estimate the occurrence of dementia in Norway as a whole, by age, sex and severity of dementia. Furthermore, the proportion of people without dementia diagnosis among those with dementia will be examined. Information about known dementia diagnosis from dementia assessment in municipality or specialist health service will be obtained by linking to registered data. The investigators will further investigate whether there are differences in dementia prevalence between males and females and educational groups and look at factors associated with a lack of diagnosis. Information from the earlier waves of HUNT (1-4) will be used to get information on health and risk factors for dementia from the study population.

Eligibility criteria: Inclusion Criteria:

* Living in the designated area

Exclusion Criteria:

* None

Primary outcomes:
measure: Dementia criteria in DSM-5
timeFrame: Each participant is evaluated against dementia criteria in DSM- after participation, based on assessment done in the 20 month long assessment period
Secondary outcomes:
measure: Montreal Cognitive Assessment
timeFrame: Each participant were assessed once during an assessment period of 20 months
measure: CERAD Ten-word test
timeFrame: Each participant is assessed once during an assessment period of 20 months
measure: Severe Impairment Battery
timeFrame: Participants in institution with known moderate to severe dementia is assessed once during an assessment period of 20 months
measure: Hospital Anxiety and Depression Scale
timeFrame: Each participant is assessed once during an assessment period of 20 months.
measure: Instrumental Activities in Daily Living Scale
timeFrame: Assessed in proxy interview during interview period of 22 months
measure: Physical Self-Maintenance Scale
timeFrame: 20 months
measure: Neuropsychiatric Inventory
timeFrame: 22 months
measure: Clinical Dementia Rating Scale
timeFrame: 22 months
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: Norwegian National Advisory Unit on Ageing and Health
Study officials:
affiliation: Norwegian National Advisory Unit on Ageing and Health
name: Geir Selbæk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engedal K, Gjora L, Benth JS, Wagle J, Ronqvist TK, Selbaek G. The Montreal Cognitive Assessment: Normative Data from a Large, Population-Based Sample of Cognitive Healthy Older Adults in Norway-The HUNT Study. J Alzheimers Dis. 2022;86(2):589-599. doi: 10.3233/JAD-215442.
citation: Gjora L, Strand BH, Engedal K, Ernstsen L, Myrstad C, Skjellegrind H, Thingstad P, Selbaek G. Dementia and mild cognitive impairment in older people in Trondelag. Tidsskr Nor Laegeforen. 2023 Jun 26;143(10). doi: 10.4045/tidsskr.22.0815. Print 2023 Jun 27. English, Norwegian.
citation: Wagle J, Selbaek G, Benth JS, Gjora L, Ronqvist TK, Bekkhus-Wetterberg P, Persson K, Engedal K. The CERAD Word List Memory Test: Normative Data Based on a Norwegian Population-Based Sample of Healthy Older Adults 70 Years and Above. The HUNT Study. J Alzheimers Dis. 2023;91(1):321-343. doi: 10.3233/JAD-220672.
citation: GjOra L, Strand BH, Bergh S, Borza T, Braekhus A, Engedal K, Johannessen A, Kvello-Alme M, Krokstad S, Livingston G, Matthews FE, Myrstad C, Skjellegrind H, Thingstad P, Aakhus E, Aam S, Selbaek 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.