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CompletedNCT02055092Updated Mar 8, 2021

Young Onset Dementia - the Difficult Diagnosis and the Stressful Life for the Whole Family

An observational study in Frontotemporal Dementia and Alzheimer Disease, sponsored by Norwegian Centre for Ageing and Health. Completed at 1 site in Norway. Open to participants aged Up to 69 Years. Per ClinicalTrials.gov, last updated 2021-03-08.

Sponsored by Norwegian Centre for Ageing and Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
Up to 69 Years
Sex
All
01

Study 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 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:

  1. QoL is poorer among persons with FTD and their families compared to AD at baseline.
  2. There is less worsening of QoL after two years in persons with AD and their families compared to FTD.
  3. People with YOD have different needs for health care services than older people with dementia.
  4. 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:

  1. To evaluate the quality of life of persons with YOD and their family members.
  2. To identify and explore the specific needs of YOD and their families.
  3. To assess the use of health resources and calculate the costs associated with care for YOD, in comparison with older persons with dementia.
  4. 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:

  1. 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
  2. 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.
  3. 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.
  4. 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.

02

Conditions studied

  • Frontotemporal Dementia
  • Alzheimer Disease

Keywords

  • Young onset dementia
  • Quality of life
  • Specific needs
  • Healthcare resources in dementia
  • Frontotemporal dementia
  • Alzheimer's disease
  • Healthcare services
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 250 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Norwegian Centre for Ageing and Health is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 69 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

YOD participants are community residing persons recruited from memory clinics in Norway and Nordic countries (Iceland, Sweden and Denmark).

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline

  2. 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).

    Time frame: Baseline, 12 months

  3. 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).

    Time frame: Baseline, 24 months

Secondary outcomes

  1. Specific needs

    Assessments by Camberwell Assessment of Need in the Elderly (CANE); 24 items for index person and 2 items for family member needs.

    Time frame: Baseline

  2. Use of healthcare resources

    Assessments by Resource utilization in dementia Lite (RUD Lite).

    Time frame: Baseline

  3. 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).

    Time frame: Baseline

  4. Neuropsychiatric symptoms

    Assessments by Neuropsychiatric Inventory- Questionnaire (NPI-Q).

    Time frame: Baseline

  5. Activities of Daily Living (ADL)

    Assessments by Lawton \& Brody I-ADL and Physical Self-maintenance Scale (PSMS).

    Time frame: Baseline

  6. Relative's stress

    Assessments by Relative's Stress Scale (RSS).

    Time frame: Baseline

  7. Specific needs

    Assessments by Camberwell Assessment of Need in the Elderly (CANE); 24 items for index person and 2 items for family member needs.

    Time frame: 12 months

  8. Specific needs

    Assessments by Camberwell Assessment of Need in the Elderly (CANE); 24 items for index person and 2 items for family member needs.

    Time frame: 24 months

  9. Use of healthcare resources

    Assessments by Resource utilization in dementia Lite (RUD Lite).

    Time frame: 12 months

  10. Use of healthcare resources

    Assessments by Resource utilization in dementia Lite (RUD Lite).

    Time frame: 24 months

  11. 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).

    Time frame: 12 months

  12. 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).

    Time frame: 24 months

  13. Neuropsychiatric symptoms

    Assessments by Neuropsychiatric Inventory- Questionnaire (NPI-Q).

    Time frame: 12 months

  14. Neuropsychiatric symptoms

    Assessments by Neuropsychiatric Inventory- Questionnaire (NPI-Q).

    Time frame: 24 months

  15. Activities of Daily Living (ADL)

    Assessments by Lawton \& Brody I-ADL and Physical Self-maintenance Scale (PSMS).

    Time frame: 12 months

  16. Relative's stress

    Assessments by Relative's Stress Scale (RSS).

    Time frame: 12 months

  17. Activities of Daily Living (ADL)

    Assessments by Lawton \& Brody I-ADL and Physical Self-maintenance Scale (PSMS).

    Time frame: 24 months

  18. Relative's stress

    Assessments by Relative's Stress Scale (RSS).

    Time frame: 24 months

Other outcomes

  1. Clinical dementia rating

    Assessments by Clinical dementia rating scale (CDR) .

    Time frame: Baseline

  2. Awareness

    Assessments by REED scale.

    Time frame: Baseline

  3. Depressive symptoms

    Assessments by Cornell Scale for Depression in Dementia (CSDD) by proxy, and using Geriatric Depression Scale (GDS) and Montgomery-Asberg Depression Rating Scale (MADRS) in family member.

    Time frame: Baseline

  4. Coping

    Assessments by Locus, 17 item, for index person and family member.

    Time frame: Baseline

  5. Intercurrent disease

    Assessments by telephone follow-up interview with index person and family member.

    Time frame: 6 months

  6. Medication

    Time frame: Baseline

  7. Hospital admission

    Assessments by telephone follow-up interview with index person and family member.

    Time frame: 6 months

  8. Changes in living conditions

    Assessments by telephone follow-up interview with index person and family member.

    Time frame: 6 months

  9. Major life events

    Assessments by telephone follow-up interview with index person and family member.

    Time frame: 6 months

  10. Apo E4-genotype

    Whole blood collected at baseline, analysis may be performed at a later stage (stored in research bio bank).

    Time frame: Baseline

  11. Clinical dementia rating

    Assessments by Clinical dementia rating scale (CDR) .

    Time frame: 12 months

  12. Clinical dementia rating

    Assessments by Clinical dementia rating scale (CDR) .

    Time frame: 24 months

  13. Awareness

    Assessments by REED scale.

    Time frame: 12 months

  14. Awareness

    Assessments by REED scale.

    Time frame: 24 months

  15. Depressive symptoms

    Assessments by Cornell Scale for Depression in Dementia (CSDD) by proxy, and using Geriatric Depression Scale (GDS) and Montgomery-Asberg Depression Rating Scale (MADRS) in family member.

    Time frame: 12 months

  16. Depressive symptoms

    Assessments by Cornell Scale for Depression in Dementia (CSDD) by proxy, and using Geriatric Depression Scale (GDS) and Montgomery-Asberg Depression Rating Scale (MADRS) in family member.

    Time frame: 24 months

  17. Coping

    Assessments by Locus, 17 item, for index person and family member.

    Time frame: 12 months

  18. Coping

    Assessments by Locus, 17 item, for index person and family member.

    Time frame: 24 months

  19. Intercurrent disease

    Assessments by telephone follow-up interview with index person and family member.

    Time frame: 18 months

  20. Medication

    Time frame: 12 months

  21. Medication

    Time frame: 24 months

  22. Medication

    Time frame: 6 months

  23. Medication

    Time frame: 18 months

  24. Hospital admission

    Assessments by telephone follow-up interview with index person and family member.

    Time frame: 18 months

  25. Changes in living conditions

    Assessments by telephone follow-up interview with index person and family member.

    Time frame: 18 months

  26. Major life events

    Assessments by telephone follow-up interview with index person and family member.

    Time frame: 18 months

07

Study locations

1 site
  • Norwegian Centre for Ageing and Health
    Tønsberg, Vestfold 3103, Norway
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02055092
Lead sponsor
Norwegian Centre for Ageing and Health
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
First posted
Feb 4, 2014
Start date
Feb 2014
Primary completion
Jun 2017
Completion
Jul 2020
Last update
Mar 8, 2021

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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