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

Not yet recruiting

• Conditions: Young-onset Dementia
• Interventions: Other: Neuropsychological assessment, driving simulator task

• 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

Arm && Interventions

Group	Intervention	Description
non-bvYOD	Neuropsychological assessment, driving simulator task	Neuropsychological assessment and driving simulator task.
Healthy controls	Neuropsychological assessment, driving simulator task	Neuropsychological assessment and driving simulator task.
bvYOD	Neuropsychological assessment, driving simulator task	Neuropsychological assessment and driving simulator task.
Patients with frontal brain damage	Neuropsychological assessment, driving simulator task	Neuropsychological assessment and driving simulator task.

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.