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

Not yet recruiting

• Conditions: Young-onset Dementia

• Registration Number: NCT06286293
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-22
• Study First Submitted QC: 2024-02-28
• Study First Posted: 2024-02-29
• Status Verified: 2024-06
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Study Start: 2025-02-04
• Primary Completion: 2026-06-30
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 140

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Social cognitive performance	2024-2027	Social cognition in bvYOD, compared to non-bvYOD, patients with frontal brain injury and healthy controls

Secondary Outcome Measures

Name	Time	Method
Association between social cognition and risky decision-making	2024-2027	Association between several aspect of social cognition (i.e. emotion recognition, empathy, theory of mind, emotion experience) and risk-taking behaviour.