YOD-RiSoCo: Social Cognition and Risk-taking Behaviour in Patients with Young-onset Dementia (YOD-RiSoCo)
January 8, 2025 updated by: University Medical Center Groningen
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
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gelmers
- Phone Number: +31 50 361 46 64
- Email: f.gelmers@umcg.nl
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
bvYOD
Neuropsychological assessment and 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.
|
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 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 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
Time Frame: 2024-2027
|
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
Time Frame: 2024-2027
|
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
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.