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NCT Number: NCT06286293

YOD-RiSoCo: Social Cognition and Risk-taking Behaviour in Patients with Young-onset Dementia

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Neuropsychological assessment, driving simulator task

Other

Neuropsychological assessment consisting of test measuring general cognitive abilities and social cognition. Driving simulator task measuring risk-taking.

Primary outcomes

  1. Social cognitive performance

    Time frame: 2024-2027

    Social cognition in bvYOD, compared to non-bvYOD, patients with frontal brain injury and healthy controls

Secondary outcomes

  1. Association between social cognition and risky decision-making

    Time frame: 2024-2027

    Association between several aspect of social cognition (i.e. emotion recognition, empathy, theory of mind, emotion experience) and risk-taking behaviour.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

Registry information

Official study title

YOD-RiSoCo: the Role of Social Cognition and Better Identification of Risk-taking Behaviour in Patients with Young-onset Dementia

Acronym: YOD-RiSoCo

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 29, 2024
Registry last updated
Jan 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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