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

NCT06286293 | Not Yet Recruiting

• 1 other identifier: 18171
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Social cognitive performance

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

  2024-2027

Secondary Outcomes (1)

• Association between social cognition and risky decision-making

  2024-2027

Study Arms (4)

bvYOD

Neuropsychological assessment and driving simulator task.

Other: Neuropsychological assessment, driving simulator task

non-bvYOD

Neuropsychological assessment and driving simulator task.

Other: Neuropsychological assessment, driving simulator task

Patients with frontal brain damage

Neuropsychological assessment and driving simulator task.

Other: Neuropsychological assessment, driving simulator task

Healthy controls

Neuropsychological assessment and driving simulator task.

Other: Neuropsychological assessment, driving simulator task

Interventions

Neuropsychological assessment, driving simulator task OTHER

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

Healthy controls; Patients with frontal brain damage; bvYOD; non-bvYOD

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with young-onset dementia, i.e. onset of dementia before the age of 65 years.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Medical Center Groningen: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Related Publications (1)

• 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.

  PMID: 40424326 DERIVED

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Central Study Contacts

Gelmers

CONTACT

+31 50 361 46 64; f.gelmers@umcg.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: February 4, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: January 10, 2025

Record last verified: 2024-06