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

NCT02055092 | Completed

• 1 other identifier: 229002
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  Baseline, 24 months

Secondary Outcomes (18)

• Specific needs

  Baseline

• Use of healthcare resources

  Baseline

• Cognition

  Baseline

• Neuropsychiatric symptoms

  Baseline

• Activities of Daily Living (ADL)

  Baseline

Other Outcomes (26)

• Clinical dementia rating

  Baseline

• Awareness

  Baseline

• Depressive symptoms

  Baseline

Study Arms (3)

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.

Eligibility Criteria

• Age: Up to 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian Centre for Ageing and Health: lead
• The Research Council of Norway: collaborator
• The Hospital of Vestfold: collaborator
• Oslo University Hospital: collaborator
• Sykehuset Innlandet HF: collaborator
• Haraldsplass Deaconess Hospital: collaborator
• Karolinska University Hospital: collaborator
• Copenhagen University Hospital, Denmark: collaborator
• Zealand University Hospital: collaborator
• Landspitali University Hospital: collaborator
• Sykehuset Telemark: collaborator

Study Sites (1)

Norwegian Centre for Ageing and Health

Tønsberg, Vestfold, 3103, Norway

Location

Related Publications (1)

• 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.

  PMID: 31106576 DERIVED

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.

MeSH Terms

Conditions

Frontotemporal Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; TDP-43 Proteinopathies; Neurodegenerative Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies

Study Officials

• Geir Selbæk, MD, PhD

  Norwegian Centre for Ageing and Health

  STUDY DIRECTOR

• Hege Kersten, CPh, PhD

  Norwegian Centre for Ageing and Health

  STUDY CHAIR

• Aud Johannessen, DrPH

  Norwegian Centre for Ageing and Health

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 4, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2020
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

NO (1)