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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Norwegian Centre for Ageing and Health
Sponsor:
Collaborators:
The Research Council of Norway
Vestfold Hospital Trust
Oslo University Hospital
Sykehuset Innlandet HF
Haraldsplass Deaconess Hospital
Karolinska University Hospital
Copenhagen University Hospital, Denmark
Roskilde Hospital
Landspitali University Hospital
Sykehuset Telemark
Information provided by (Responsible Party):
Norwegian Centre for Ageing and Health
ClinicalTrials.gov Identifier:
NCT02055092
First received: January 31, 2014
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition
Frontotemporal Dementia
Alzheimer's Disease.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Norwegian Centre for Ageing and Health:

Primary Outcome Measures:
  • Quality of life [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Specific needs [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessments by Camberwell Assessment of Need in the Elderly (CANE); 24 items for index person and 2 items for family member needs.

  • Use of healthcare resources [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessments by Resource utilization in dementia Lite (RUD Lite).

  • Cognition [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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).

  • Neuropsychiatric symptoms [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessments by Neuropsychiatric Inventory- Questionnaire (NPI-Q).

  • Activities of Daily Living (ADL) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessments by Lawton & Brody I-ADL and Physical Self-maintenance Scale (PSMS).

  • Relative's stress [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessments by Relative's Stress Scale (RSS).

  • Specific needs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessments by Camberwell Assessment of Need in the Elderly (CANE); 24 items for index person and 2 items for family member needs.

  • Specific needs [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessments by Camberwell Assessment of Need in the Elderly (CANE); 24 items for index person and 2 items for family member needs.

  • Use of healthcare resources [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessments by Resource utilization in dementia Lite (RUD Lite).

  • Use of healthcare resources [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessments by Resource utilization in dementia Lite (RUD Lite).

  • Cognition [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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).

  • Cognition [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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).

  • Neuropsychiatric symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessments by Neuropsychiatric Inventory- Questionnaire (NPI-Q).

  • Neuropsychiatric symptoms [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessments by Neuropsychiatric Inventory- Questionnaire (NPI-Q).

  • Activities of Daily Living (ADL) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessments by Lawton & Brody I-ADL and Physical Self-maintenance Scale (PSMS).

  • Relative's stress [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessments by Relative's Stress Scale (RSS).

  • Activities of Daily Living (ADL) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessments by Lawton & Brody I-ADL and Physical Self-maintenance Scale (PSMS).

  • Relative's stress [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessments by Relative's Stress Scale (RSS).


Other Outcome Measures:
  • Clinical dementia rating [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessments by Clinical dementia rating scale (CDR) .

  • Awareness [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessments by REED scale.

  • Depressive symptoms [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Coping [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessments by Locus, 17 item, for index person and family member.

  • Intercurrent disease [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessments by telephone follow-up interview with index person and family member.

  • Medication [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Hospital admission [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessments by telephone follow-up interview with index person and family member.

  • Changes in living conditions [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessments by telephone follow-up interview with index person and family member.

  • Major life events [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessments by telephone follow-up interview with index person and family member.

  • Apo E4-genotype [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Whole blood collected at baseline, analysis may be performed at a later stage (stored in research bio bank).

  • Clinical dementia rating [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessments by Clinical dementia rating scale (CDR) .

  • Clinical dementia rating [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessments by Clinical dementia rating scale (CDR) .

  • Awareness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessments by REED scale.

  • Awareness [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessments by REED scale.

  • Depressive symptoms [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.

  • Depressive symptoms [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.

  • Coping [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assessments by Locus, 17 item, for index person and family member.

  • Coping [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Assessments by Locus, 17 item, for index person and family member.

  • Intercurrent disease [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Assessments by telephone follow-up interview with index person and family member.

  • Medication [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Medication [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Medication [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Medication [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Hospital admission [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Assessments by telephone follow-up interview with index person and family member.

  • Changes in living conditions [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Assessments by telephone follow-up interview with index person and family member.

  • Major life events [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Assessments by telephone follow-up interview with index person and family member.


Biospecimen Retention:   Samples With DNA

Bio samples are collected for analysis and storage in a bio bank as part of the routines for the National Registry of Dementia:

  • Blood plasma and serum for the later analysis of inflammation markers.
  • Whole blood for analysis of apolipoprotein E4-genotype.
  • Cerebrospinal fluid for dementia markers (tau-protein, amyloid).
  • Saliva cortisol.

Estimated Enrollment: 250
Study Start Date: February 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
YOD-FTD
Young onset dementia - frontotemporal dementia, 75 persons with their respective family members.
YOD-AD
Young onset dementia - Alzheimer's disease, 75 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.

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.

  Eligibility

Ages Eligible for Study:   up to 69 Years
Genders Eligible for Study:   Both
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).

Criteria

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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055092

Contacts
Contact: Lara Hvidsten, MD +4795166067 lara.hvidsten@aldringoghelse.no
Contact: Knut Engedal, Prof.dr.med, PhD +4791590433 knut.engedal@aldringoghelse.no

Locations
Norway
Norwegian Centre for Ageing and Health Recruiting
Tønsberg, Vestfold, Norway, 3103
Contact: Lara Hvidsten, MD    +4795166067    lara.hvidsten@aldringoghelse.no   
Norwegian Centre for Ageing and Health Recruiting
Tønsberg, Vestfold, Norway, 3103
Contact: Aud Johannessen, DrPH    +47975 47 979    aud.johannessen@aldringoghelse.no   
Sponsors and Collaborators
Norwegian Centre for Ageing and Health
The Research Council of Norway
Vestfold Hospital Trust
Oslo University Hospital
Sykehuset Innlandet HF
Haraldsplass Deaconess Hospital
Karolinska University Hospital
Copenhagen University Hospital, Denmark
Roskilde Hospital
Landspitali University Hospital
Sykehuset Telemark
Investigators
Study Director: Geir Selbæk, MD, PhD Norwegian Centre for Ageing and Health
Study Chair: Hege Kersten, Cand.pharm, PhD Norwegian Centre for Ageing and Health
Study Chair: Aud Johannessen, DrPH Norwegian Centre for Ageing and Health
  More Information

No publications provided

Responsible Party: Norwegian Centre for Ageing and Health
ClinicalTrials.gov Identifier: NCT02055092     History of Changes
Other Study ID Numbers: 229002
Study First Received: January 31, 2014
Last Updated: April 2, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian Centre for Ageing and Health:
Young onset dementia
Quality of life
Specific needs
Healthcare resources in dementia
Frontotemporal dementia
Alzheimer's disease
Healthcare services

Additional relevant MeSH terms:
Dementia
Frontotemporal Dementia
Delirium, Dementia, Amnestic, Cognitive Disorders
Alzheimer Disease
Aphasia, Primary Progressive
Pick Disease of the Brain
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Aphasia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 23, 2014