DementiaNCT04289389
Prevalence and Level of Diagnosis of Dementia in a Population-based Sample in the County of Trøndelag
An observational study of Dementia, run by Norwegian Centre for Ageing and Health at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- How many people
- 11,675 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2018to 7 Apr 2026
- 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: Persons of 70 years of age or older participated in HUNT4 and accepted cognitive screening in HUNT4 70+.
Who may be able to join
- Living in the designated area
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dementia
- Keywords
- Prevalence, Epidemiology, Alzheimer's disease
- Medical subject headings
- Dementia, Alzheimer Disease
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 in Nord-Trøndelag 70 years of age and older were invited. | |
| HUNT4 Trondheim 70+ | All inhabitants of one district in Trondheim 70 years of age and older were invited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dementia criteria in DSM-5
Used to assess prevalence of dementia in the study population
Measured: Each participant is evaluated against dementia criteria in DSM- after participation, based on assessment done in the 20 month long assessment period
Secondary outcomes (8)
Montreal Cognitive Assessment
Tests cognitive function in the domain's memory, visuospatial and executive functions, attention, concentration, language and orientation. Scores from 0 - 30 where 30 indicates best function.
Measured: Each participant were assessed once during an assessment period of 20 months
CERAD Ten-word test
Tests immediate and delayed memory. Scores from 0 - 30 in immediate memory and 0-10 in delayed recall, higher scores indicates better function.
Measured: Each participant is assessed once during an assessment period of 20 months
Severe Impairment Battery
Tests cognitive function in people with moderate to severe dementia. Scores from 0 - 16 where 16 indicates best function.
Measured: Participants in institution with known moderate to severe dementia is assessed once during an assessment period of 20 months
Hospital Anxiety and Depression Scale
Gathers information on anxiety and depression, scores from 0 - 42 where 0 indicates best function
Measured: Each participant is assessed once during an assessment period of 20 months.
Instrumental Activities in Daily Living Scale
Assess problems with instrumental activities of daily living, scores function in 8 instrumental activities, lower scores indicates better function
Measured: Assessed in proxy interview during interview period of 22 months
Physical Self-Maintenance Scale
Assess problems with personal activities of daily living. Assessed in proxy interview and by health personnel for participants in institutions, scores function in 6 personal activities, lower scores indicates better function
Measured: 20 months
Neuropsychiatric Inventory
Assess neuropsychiatric symptoms, screening questions on each symptom and a score for frequency from 1-4, severity 1-3 and distress 1-5, higher scores indicates more severe symptoms
Measured: 22 months
Clinical Dementia Rating Scale
Assess degree of cognitive decline and function level, scores from 0-3 where higher score indicates more cognitive decline and lower function level
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start1 Jan 2018
- Primary completion7 Apr 2026
- Study completion7 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Prospective
- Enrolment
- 11,675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Centre for Ageing and Health
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Health Association, University of Oslo
- Responsible party
- Sponsor
- Investigators
- Geir Selbæk, PhD, Principal investigator, Norwegian National Advisory Unit on Ageing and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04289389
- Sponsor's protocol ID
- 181124
- Status last verified
- Apr 2026
- First submitted
- 6 Feb 2020
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35094994Gjora 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.
PubMed 37376934Wagle 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.
PubMed 36404547GjOra 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.
PubMed 33427745
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Level of Diagnosis of Dementia in a Population-based Sample in the County of Trøndelag
- ClinicalTrials.gov ID
- NCT04289389
- Acronym / sponsor ID
- 181124
- Conditions
- Dementia
- Keywords
- Prevalence, Epidemiology, Alzheimer's disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11,675 participants (actual)
- Lead sponsor
- Norwegian Centre for Ageing and HealthUniversity, hospital or other
- Collaborators
- Norwegian Health Association, University of Oslo
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 7 Apr 2026 (actual)
- Study completion
- 7 Apr 2026 (actual)
- First posted
- 28 Feb 2020 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HUNT4 70+ | – | –All inhabitants in Nord-Trøndelag 70 years of age and older were invited. |
| HUNT4 Trondheim 70+ | – | –All inhabitants of one district in Trondheim 70 years of age and older were invited. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Persons of 70 years of age or older participated in HUNT4 and accepted cognitive screening in HUNT4 70+.
Key inclusion criteria (1 listed)
- Living in the 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
Dementia criteria in DSM-5
Time frame: Each participant is evaluated against dementia criteria in DSM- after participation, based on assessment done in the 20 month long assessment period
Used to assess prevalence of dementia in the study population
8 secondary outcomes
Montreal Cognitive Assessment
Time frame: Each participant were assessed once during an assessment period of 20 months
CERAD Ten-word test
Time frame: Each participant is assessed once during an assessment period of 20 months
Severe Impairment Battery
Time frame: Participants in institution with known moderate to severe dementia is assessed once during an assessment period of 20 months
Hospital Anxiety and Depression Scale
Time frame: Each participant is assessed once during an assessment period of 20 months.
Instrumental Activities in Daily Living Scale
Time frame: Assessed in proxy interview during interview period of 22 months
Physical Self-Maintenance Scale
Time frame: 20 months
Neuropsychiatric Inventory
Time frame: 22 months
Clinical Dementia Rating Scale
Time frame: 22 months
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 13 Apr 2026.
- Background: PubMed 35094994Engedal 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.
- Background: PubMed 37376934Gjora 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.
- Background: PubMed 36404547Wagle 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.
- Results publication: PubMed 33427745GjOra 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.
- Website that shows the current and future prevalence of dementia in the different regions and municipalities in NorwayLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Dementia
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Recruiting
Technology-Based Intervention Pilot Testing
Dementia, Elder Abuse
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingPhase 2/3
Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Alzheimer's Disease Dementia
Agitation Associated With Alzheimer's Disease Dementia
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, 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 13 Apr 2026. 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?
Dementia criteria in DSM-5 (time frame: Each participant is evaluated against dementia criteria in DSM- after participation, based on assessment done in the 20 month long assessment period). 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 NCT04289389, which also lists 4 linked publications.
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 13 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.