Clinical trial NCT06286293: YOD-RiSoCo: Social Cognition and Risk-taking Behaviour in Patients with Young-onset Dementia
Official title: YOD-RiSoCo: the Role of Social Cognition and Better Identification of Risk-taking Behaviour in Patients with Young-onset Dementia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Young-onset Dementia
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2024-02-29
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with young-onset dementia, i.e. onset of dementia before the age of 65 years.

Brief summary: The goal of this observational study is to learn about social cognition and risky behaviour in patients with young-onset dementia (YOD). The investigators want to

* Examine differences in performance on social cognition test and measures of risky behaviour between behavioural variant YOD patients, patients with frontal brain injury, non-behavioural YOD patients and healthy controls.
* Examine if there is a relation between social cognition tests and measures of risky behaviour.

Participants will be administered a neuropsychological assessment including social cognition measures and patients will complete a driving simulator task in which risky behaviour will be elicited.


Eligibility criteria: Inclusion Criteria:

All subjects

* Sufficient command of the Dutch language
* In possession of a driver's license with any driving experience throughout life
* Age 18 to 65

bvYOD subjects

* Probable diagnosis of young-onset dementia (before 65 years old), confirmed after interdisciplinary consensus meeting in which interviews, neuropsychological examination, neurological and psychiatric assessments, neuro-imaging, blood samples, and in some cases FDG/PIB-PETscans, CSF biomarkers or genetic counseling were discussed.
* Nosological diagnosis of bvFTD or bvAD

Non-bvYOD subjects

* Probable diagnosis of young-onset dementia (before 65 years old), confirmed after interdisciplinary consensus meeting in which interviews, neuropsychological examination, neurological and psychiatric assessments, neuro-imaging, blood samples, and in some cases FDG/PIB-PETscans, CSF biomarkers or genetic counseling were discussed.
* YOD subtypes other dan bvFTD or bvAD, such as amnestic variant AD.

Frontal brain injury subjects

- Neurological patients with frontal brain injury (e.g. traumatic brain injury, stroke or brain tumor patients).

Exclusion Criteria:

All subjects

* Suffering from severe motion sickness; motion sickness is a risk factor for simulator sickness

YOD subjects:

- Presence of premorbid severe neurological or psychiatric pathology, non-related to dementia.

Frontal brain injury subjects:

- Presence of serious psychiatric disorders or other neurological comorbidities.

Healthy control subjects:

* Presence of serious psychiatric disorders
* History of neurological disorders, which may interfere with cognitive functioning (e.g. recent concussion, previous subarachnoid or intracerebral haemorrhage, intracranial tumours, epilepsy, ischemic stroke).

Primary outcomes:
measure: Social cognitive performance
timeFrame: 2024-2027
Secondary outcomes:
measure: Association between social cognition and risky decision-making
timeFrame: 2024-2027
Other outcomes:
Locations:
Study officials:
References: