Frontotemporal DementiaNCT02055092
Young Onset Dementia - the Difficult Diagnosis and the Stressful Life for the Whole Family
An observational study of Frontotemporal Dementia and Alzheimer Disease, run by Norwegian Centre for Ageing and Health at 1 site in Norway.
Trial summary
People diagnosed with young onset dementia are today mostly assigned to the same healthcare services as people developing dementia at an older age. They and their families are however in a quite different life situation, which is likely to generate different challenges and specific needs for tailored healthcare… Read more about this study
- Who is it for?
- Ages Up to 69 years
- Conditions the study is for
- Frontotemporal Dementia, Alzheimer Disease
- How many people
- 250 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2014to Jul 2020
- 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 Up to 69 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: YOD participants are community residing persons recruited from memory clinics in Norway and Nordic countries (Iceland, Sweden and Denmark).
Who may be able to join
- Debut of dementia symptoms before the age of 65 years, but age at time of inclusion may be up to 70 years.
- FTD (Neary et al 1998 criteria)
- Primary progressive aphasia (Mesulam 2003 criteria)
- AD (DSM-IV)
- Community living, excl. dementia-specific living facilities manned 24/7
- Family member with regular contact at least x 1/week.
Who cannot join
- Lack of informed consent
- No close or appropriate family member
- Frontal lobe dysfunction due to non-progressive injury, i.e. cerebral infarction
- Frontal lobe dysfunction due to motor neuron disease (ALS)
- Other dementia specific condition with frontal lobe dysfunction (Huntington, HIV, Down syndrome, alcoholic dementia)
- Mental retardation
- Current substance abuse, incl. excessive alcohol consumption for the past 12 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Nordic Multicentre Observational Study of Persons With Young Onset Dementia and Their Families - Factors Influencing Quality of Life, Theirs Specific Needs and the Use of Healthcare Resources
People diagnosed with young onset dementia are today mostly assigned to the same healthcare services as people developing dementia at an older age. They and their families are however in a quite different life situation, which is likely to generate different challenges and specific needs for tailored healthcare services, of importance in maintaining their perceived quality of life.
The investigators of this study wish to assess the factors influencing these families' quality of life, their specific needs and their use of healthcare services by the use a combination of quantitative and qualitative methods. The main aim of this study is to provide better future healthcare services to these families, and to develop a programme for optimal collaboration between specialist healthcare services and the local dementia teams.
Read the detailed description
Background: Most common dementia cases in Young Onset dementia (YOD) are Alzheimer's disease (AD) and frontotemporal dementia (FTD). There is little knowledge about the impact on the affected families, especially with regard to FTD. Although their life situation and specific needs differ from that of older people, they are referred to the same healthcare services.
Hypothesis:
- QoL is poorer among persons with FTD and their families compared to AD at baseline.
- There is less worsening of QoL after two years in persons with AD and their families compared to FTD.
- People with YOD have different needs for health care services than older people with dementia.
- YOD and their families have more unmet needs than older people with dementia.
Methods: Nordic multicenter observational cohort study of YOD-AD and YOD-FTD. 75 persons in each group, living at home with their families, recruited from five Norwegian and four Nordic memory clinics. The control group consists of 100 older people with dementia age ≥70 years. The investigators use a combination of quantitative and qualitative methods.
The follow-up period of the persons with YOD and their family members is two years. Assessments are made at baseline, 12 and 24 months, with telephone check-ups at 6 and 18 months. The main assessment questionnaires are Quality of life in Alzheimer's disease (QoL-AD), Camberwell Assessment of Need in the Elderly (CANE), and Resource Utilization in Dementia Lite (RUD Lite).
Study aims for the quantitative part of the study:
- To evaluate the quality of life of persons with YOD and their family members.
- To identify and explore the specific needs of YOD and their families.
- To assess the use of health resources and calculate the costs associated with care for YOD, in comparison with older persons with dementia.
- To compare the functional characteristics of YOD with older people with dementia in terms of cognitive decline, impairment of activities of daily living, changes in behavior, and quality of life.
Study aims and methods for the qualitative part of the study:
- To investigate how people living alone with young-onset dementia cope with everyday life and decision-making. A longitudinal study with qualitative interviews at 6, 12, 24, 36 and 48 months after initial diagnosis
- To investigate how it is to be a spouse/cohabitation to a person with young-onset of frontotemporal dementia. A retrospective and prospective study with qualitative interviews.
- To investigate adult children's experiences with the support they received after their parent with young-onset dementia received a dementia diagnose. A retrospective and prospective study with qualitative interviews.
- To investigate carers of people with young-onset dementia experiences with the support contact service. A longitudinell study study with qualitative interviews.
Results: Inclusion starts Feb 2014. The objective of this study is to ensure optimally tailored service provision and future healthcare planning according to the specific needs of families of YOD, and develop a care programme in collaboration between primary and specialist healthcare services.
- Conditions
- Frontotemporal Dementia, Alzheimer Disease
- Keywords
- Young onset dementia, Quality of life, Specific needs, Healthcare resources in dementia, Frontotemporal dementia, Alzheimer's disease, Healthcare services
- Medical subject headings
- Frontotemporal 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 |
|---|---|---|
| YOD-FTD | Young onset dementia - frontotemporal dementia, 38 persons with their respective family members. | |
| YOD-AD | Young onset dementia - Alzheimer's disease, 50 persons with their respective family members. | |
| LOD | Late onset dementia >= 70 years of age; Control group of 100 persons with dementia (mostly AD and AD/vascular) and their respective family members. Data already collected in a previous study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Assessments by Quality of Life - Alzheimer's dementia (QoL-AD) and Euroqol-5D (EQ-5D), index person and family member; also by proxy (QoL-AD).
Measured: Baseline
Change from baseline in quality of life at 12 months
Assessments by Quality of Life - Alzheimer's dementia (QoL-AD) and Euroqol-5D (EQ-5D), index person and family member; also by proxy (QoL-AD).
Measured: Baseline, 12 months
Change from baseline in quality of life at 24 months
Assessments by Quality of Life - Alzheimer's dementia (QoL-AD) and Euroqol-5D (EQ-5D), index person and family member; also by proxy (QoL-AD).
Measured: Baseline, 24 months
Secondary outcomes (18)
Specific needs
Assessments by Camberwell Assessment of Need in the Elderly (CANE); 24 items for index person and 2 items for family member needs.
Measured: Baseline
Use of healthcare resources
Assessments by Resource utilization in dementia Lite (RUD Lite).
Measured: Baseline
Cognition
Assessments standardized by the National Registry of Dementia: Mini Mental Status-Norwegian revision (MMSE-NR), Clock drawing Test, Trail making test part A and B, 10-word list memory recall and recognition test, The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) visuospatial figure copying, FAS, Boston Naming Test, Informant questionnaire-on Cognitive decline in Dementia (IQ-CODE).
Measured: Baseline
Neuropsychiatric symptoms
Assessments by Neuropsychiatric Inventory- Questionnaire (NPI-Q).
Measured: Baseline
Activities of Daily Living (ADL)
Assessments by Lawton \& Brody I-ADL and Physical Self-maintenance Scale (PSMS).
Measured: Baseline
Relative's stress
Assessments by Relative's Stress Scale (RSS).
Measured: Baseline
Specific needs
Assessments by Camberwell Assessment of Need in the Elderly (CANE); 24 items for index person and 2 items for family member needs.
Measured: 12 months
Specific needs
Assessments by Camberwell Assessment of Need in the Elderly (CANE); 24 items for index person and 2 items for family member needs.
Measured: 24 months
Use of healthcare resources
Assessments by Resource utilization in dementia Lite (RUD Lite).
Measured: 12 months
Use of healthcare resources
Assessments by Resource utilization in dementia Lite (RUD Lite).
Measured: 24 months
Cognition
Assessments standardized by the National Registry of Dementia: Mini Mental Status-Norwegian revision (MMSE-NR), Clock drawing Test, Trail making test part A and B, 10-word list memory recall and recognition test, The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) visuospatial figure copying, FAS, Boston Naming Test, Informant questionnaire-on Cognitive decline in Dementia (IQ-CODE).
Measured: 12 months
Cognition
Assessments standardized by the National Registry of Dementia: Mini Mental Status-Norwegian revision (MMSE-NR), Clock drawing Test, Trail making test part A and B, 10-word list memory recall and recognition test, The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) visuospatial figure copying, FAS, Boston Naming Test, Informant questionnaire-on Cognitive decline in Dementia (IQ-CODE).
Measured: 24 months
Neuropsychiatric symptoms
Assessments by Neuropsychiatric Inventory- Questionnaire (NPI-Q).
Measured: 12 months
Neuropsychiatric symptoms
Assessments by Neuropsychiatric Inventory- Questionnaire (NPI-Q).
Measured: 24 months
Activities of Daily Living (ADL)
Assessments by Lawton \& Brody I-ADL and Physical Self-maintenance Scale (PSMS).
Measured: 12 months
Relative's stress
Assessments by Relative's Stress Scale (RSS).
Measured: 12 months
Activities of Daily Living (ADL)
Assessments by Lawton \& Brody I-ADL and Physical Self-maintenance Scale (PSMS).
Measured: 24 months
Relative's stress
Assessments by Relative's Stress Scale (RSS).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2017
- Study completionJul 2020
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 Frontotemporal 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Centre for Ageing and Health
- Sponsor type
- University, hospital or other
- Collaborators
- The Research Council of Norway, The Hospital of Vestfold, Oslo University Hospital, Sykehuset Innlandet HF, Haraldsplass Deaconess Hospital, Karolinska University Hospital, Copenhagen University Hospital, Denmark, Zealand University Hospital, Landspitali University Hospital, Sykehuset Telemark
- Responsible party
- Sponsor
- Investigators
- Geir Selbæk, MD, PhD, Study director, Norwegian Centre for Ageing and HealthHege Kersten, CPh, PhD, Study chair, Norwegian Centre for Ageing and HealthAud Johannessen, DrPH, Study chair, Norwegian Centre for Ageing and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02055092
- Sponsor's protocol ID
- 229002
- Status last verified
- Mar 2021
- First submitted
- 31 Jan 2014
- Last updated
- 8 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Hvidsten L, Engedal K, Selbaek G, Wyller TB, Saltyte Benth J, Bruvik F, Kersten H. Quality of life of family carers of persons with young-onset compared to late-onset dementia. Aging Ment Health. 2020 Sep;24(9):1394-1401. doi: 10.1080/13607863.2019.1617245. Epub 2019 May 20.
PubMed 31106576
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nordic Multicentre Observational Study of Persons With Young Onset Dementia and Their Families - Factors Influencing Quality of Life, Theirs Specific Needs and the Use of Healthcare Resources
- ClinicalTrials.gov ID
- NCT02055092
- Acronym / sponsor ID
- 229002
- Conditions
- Frontotemporal Dementia, Alzheimer Disease
- Keywords
- Young onset dementia, Quality of life, Specific needs, Healthcare resources in dementia, Frontotemporal dementia, Alzheimer's disease, Healthcare services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Norwegian Centre for Ageing and HealthUniversity, hospital or other
- Collaborators
- The Research Council of Norway, The Hospital of Vestfold, Oslo University Hospital, Sykehuset Innlandet HF, Haraldsplass Deaconess Hospital, Karolinska University Hospital, Copenhagen University Hospital, Denmark, Zealand University Hospital, Landspitali University Hospital, Sykehuset Telemark
- Study start
- Feb 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 4 Feb 2014 (estimated)
- 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.
People diagnosed with young onset dementia are today mostly assigned to the same healthcare services as people developing dementia at an older age. They and their families are however in a quite different life situation, which is likely to generate different challenges and specific needs for tailored healthcare services, of importance in maintaining their perceived quality of life.
The investigators of this study wish to assess the factors influencing these families' quality of life, their specific needs and their use of healthcare services by the use a combination of quantitative and qualitative methods. The main aim of this study is to provide better future healthcare services to these families, and to develop a programme for optimal collaboration between specialist healthcare services and the local dementia teams.
Detailed description
Background: Most common dementia cases in Young Onset dementia (YOD) are Alzheimer's disease (AD) and frontotemporal dementia (FTD). There is little knowledge about the impact on the affected families, especially with regard to FTD. Although their life situation and specific needs differ from that of older people, they are referred to the same healthcare services.
Hypothesis:
- QoL is poorer among persons with FTD and their families compared to AD at baseline.
- There is less worsening of QoL after two years in persons with AD and their families compared to FTD.
- People with YOD have different needs for health care services than older people with dementia.
- YOD and their families have more unmet needs than older people with dementia.
Methods: Nordic multicenter observational cohort study of YOD-AD and YOD-FTD. 75 persons in each group, living at home with their families, recruited from five Norwegian and four Nordic memory clinics. The control group consists of 100 older people with dementia age ≥70 years. The investigators use a combination of quantitative and qualitative methods.
The follow-up period of the persons with YOD and their family members is two years. Assessments are made at baseline, 12 and 24 months, with telephone check-ups at 6 and 18 months. The main assessment questionnaires are Quality of life in Alzheimer's disease (QoL-AD), Camberwell Assessment of Need in the Elderly (CANE), and Resource Utilization in Dementia Lite (RUD Lite).
Study aims for the quantitative part of the study:
- To evaluate the quality of life of persons with YOD and their family members.
- To identify and explore the specific needs of YOD and their families.
- To assess the use of health resources and calculate the costs associated with care for YOD, in comparison with older persons with dementia.
- To compare the functional characteristics of YOD with older people with dementia in terms of cognitive decline, impairment of activities of daily living, changes in behavior, and quality of life.
Study aims and methods for the qualitative part of the study:
- To investigate how people living alone with young-onset dementia cope with everyday life and decision-making. A longitudinal study with qualitative interviews at 6, 12, 24, 36 and 48 months after initial diagnosis
- To investigate how it is to be a spouse/cohabitation to a person with young-onset of frontotemporal dementia. A retrospective and prospective study with qualitative interviews.
- To investigate adult children's experiences with the support they received after their parent with young-onset dementia received a dementia diagnose. A retrospective and prospective study with qualitative interviews.
- To investigate carers of people with young-onset dementia experiences with the support contact service. A longitudinell study study with qualitative interviews.
Results: Inclusion starts Feb 2014. The objective of this study is to ensure optimally tailored service provision and future healthcare planning according to the specific needs of families of YOD, and develop a care programme in collaboration between primary and specialist healthcare services.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YOD-FTD | – | –Young onset dementia - frontotemporal dementia, 38 persons with their respective family members. |
| YOD-AD | – | –Young onset dementia - Alzheimer's disease, 50 persons with their respective family members. |
| LOD | – | –Late onset dementia >= 70 years of age; Control group of 100 persons with dementia (mostly AD and AD/vascular) and their respective family members. Data already collected in a previous study. |
Who may qualify
- Ages
- Up to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- YOD participants are community residing persons recruited from memory clinics in Norway and Nordic countries (Iceland, Sweden and Denmark).
Key inclusion criteria (6 listed)
- Debut of dementia symptoms before the age of 65 years, but age at time of inclusion may be up to 70 years.
- FTD (Neary et al 1998 criteria)
- Primary progressive aphasia (Mesulam 2003 criteria)
- AD (DSM-IV)
- Community living, excl. dementia-specific living facilities manned 24/7
Key exclusion criteria (7 listed)
- Lack of informed consent
- No close or appropriate family member
- Frontal lobe dysfunction due to non-progressive injury, i.e. cerebral infarction
- Frontal lobe dysfunction due to motor neuron disease (ALS)
- Other dementia specific condition with frontal lobe dysfunction (Huntington, HIV, Down syndrome, alcoholic dementia)
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
Quality of life
Time frame: Baseline
Assessments by Quality of Life - Alzheimer's dementia (QoL-AD) and Euroqol-5D (EQ-5D), index person and family member; also by proxy (QoL-AD).
Change from baseline in quality of life at 12 months
Time frame: Baseline, 12 months
Assessments by Quality of Life - Alzheimer's dementia (QoL-AD) and Euroqol-5D (EQ-5D), index person and family member; also by proxy (QoL-AD).
Change from baseline in quality of life at 24 months
Time frame: Baseline, 24 months
Assessments by Quality of Life - Alzheimer's dementia (QoL-AD) and Euroqol-5D (EQ-5D), index person and family member; also by proxy (QoL-AD).
18 secondary outcomes
Specific needs
Time frame: Baseline
Use of healthcare resources
Time frame: Baseline
Cognition
Time frame: Baseline
Neuropsychiatric symptoms
Time frame: Baseline
Activities of Daily Living (ADL)
Time frame: Baseline
Relative's stress
Time frame: Baseline
Specific needs
Time frame: 12 months
Specific needs
Time frame: 24 months
Use of healthcare resources
Time frame: 12 months
Use of healthcare resources
Time frame: 24 months
Cognition
Time frame: 12 months
Cognition
Time frame: 24 months
Neuropsychiatric symptoms
Time frame: 12 months
Neuropsychiatric symptoms
Time frame: 24 months
Activities of Daily Living (ADL)
Time frame: 12 months
Relative's stress
Time frame: 12 months
Activities of Daily Living (ADL)
Time frame: 24 months
Relative's stress
Time frame: 24 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 8 Mar 2021.
- Derived from this study: PubMed 31106576Hvidsten L, Engedal K, Selbaek G, Wyller TB, Saltyte Benth J, Bruvik F, Kersten H. Quality of life of family carers of persons with young-onset compared to late-onset dementia. Aging Ment Health. 2020 Sep;24(9):1394-1401. doi: 10.1080/13607863.2019.1617245. Epub 2019 May 20.
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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, MD, PhD study director
Norwegian Centre for Ageing and Health
Hege Kersten, CPh, PhD study chair
Norwegian Centre for Ageing and Health
Aud Johannessen, DrPH study chair
Norwegian Centre for 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 Frontotemporal Dementia and Alzheimer Disease, 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 6 inclusion and 7 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 8 Mar 2021. 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?
Quality of life (time frame: Baseline). The study lists 3 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 NCT02055092, 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 8 Mar 2021.