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

NCT ID: NCT06286293

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-04
• Study Completion Date: 2027-03-31

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.

Conditions

Young-onset Dementia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

bvYOD

Neuropsychological assessment and driving simulator task.

Neuropsychological assessment, driving simulator task

Intervention Type: OTHER

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

non-bvYOD

Neuropsychological assessment and driving simulator task.

Neuropsychological assessment, driving simulator task

Intervention Type: OTHER

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

Patients with frontal brain damage

Neuropsychological assessment and driving simulator task.

Neuropsychological assessment, driving simulator task

Intervention Type: OTHER

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

Healthy controls

Neuropsychological assessment and driving simulator task.

Neuropsychological assessment, driving simulator task

Intervention Type: OTHER

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

Interventions

Neuropsychological assessment, driving simulator task

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

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role: collaborator

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Gelmers

Role: CONTACT

f.gelmers@umcg.nl

+31 50 361 46 64

References

Gelmers F, Huitema RB, Scheenen ME, van Munster BC, Spikman JM; YOD-INCLUDED Consortium. Assessing social cognition and risk-taking behaviour in patients with young-onset dementia: Study protocol for the YOD-RiSoCo observational prospective cohort study. PLoS One. 2025 May 27;20(5):e0324517. doi: 10.1371/journal.pone.0324517. eCollection 2025.

Reference Type: DERIVED

PMID: 40424326 (View on PubMed)

Other Identifiers

18171

Identifier Type: -

Identifier Source: org_study_id