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

YOD-RiSoCo: the Role of Social Cognition and Better Identification of 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Young-onset Dementia
• Intervention / Treatment: Other: Neuropsychological assessment, driving simulator task

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Gelmers; Phone Number: +31 50 361 46 64; Email: f.gelmers@umcg.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
bvYOD; Neuropsychological assessment and driving simulator task.	Other: Neuropsychological assessment, driving simulator task; 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.	Other: Neuropsychological assessment, driving simulator task; 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.	Other: Neuropsychological assessment, driving simulator task; 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.	Other: Neuropsychological assessment, driving simulator task; Neuropsychological assessment consisting of test measuring general cognitive abilities and social cognition. Driving simulator task measuring risk-taking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social cognitive performance	Social cognition in bvYOD, compared to non-bvYOD, patients with frontal brain injury and healthy controls	2024-2027

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Collaborators: ZonMw: The Netherlands Organisation for Health Research and Development

Study record dates

Study Major Dates

• Study Start (Estimated): February 4, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: 18171

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No