Young-onset DementiaYOD-RiSoCoNCT06286293
YOD-RiSoCo: Social Cognition and Risk-taking Behaviour in Patients with Young-onset Dementia
An observational study of Young-onset Dementia, run by University Medical Center Groningen.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Young-onset Dementia
- What is being tested?
- Neuropsychological assessment, driving simulator task
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 4 Feb 2025to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with young-onset dementia, i.e. onset of dementia before the age of 65 years.
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Young-onset Dementia
- Being tested
- Neuropsychological assessment, driving simulator task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessment, driving simulator taskOther
Neuropsychological assessment consisting of test measuring general cognitive abilities and social cognition. Driving simulator task measuring risk-taking.
| Study group | Role | What they receive |
|---|---|---|
| bvYOD | Neuropsychological assessment and driving simulator task. Receives: Other: Neuropsychological assessment, driving simulator task | |
| non-bvYOD | Neuropsychological assessment and driving simulator task. Receives: Other: Neuropsychological assessment, driving simulator task | |
| Patients with frontal brain damage | Neuropsychological assessment and driving simulator task. Receives: Other: Neuropsychological assessment, driving simulator task | |
| Healthy controls | Neuropsychological assessment and driving simulator task. Receives: Other: Neuropsychological assessment, driving simulator task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social cognitive performance
Social cognition in bvYOD, compared to non-bvYOD, patients with frontal brain injury and healthy controls
Measured: 2024-2027
Secondary outcomes (1)
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.
Measured: 2024-2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start4 Feb 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Young-onset DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286293
- Sponsor's protocol ID
- 18171
- Acronym
- YOD-RiSoCo
- Status last verified
- Jun 2024
- First submitted
- 22 Feb 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40424326
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- YOD-RiSoCo: the Role of Social Cognition and Better Identification of Risk-taking Behaviour in Patients with Young-onset Dementia
- ClinicalTrials.gov ID
- NCT06286293
- Acronym / sponsor ID
- YOD-RiSoCo / 18171
- Conditions
- Young-onset Dementia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 4 Feb 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 29 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| bvYOD | – | Other: Neuropsychological assessment, driving simulator taskNeuropsychological assessment and driving simulator task. |
| non-bvYOD | – | Other: Neuropsychological assessment, driving simulator taskNeuropsychological assessment and driving simulator task. |
| Patients with frontal brain damage | – | Other: Neuropsychological assessment, driving simulator taskNeuropsychological assessment and driving simulator task. |
| Healthy controls | – | Other: Neuropsychological assessment, driving simulator taskNeuropsychological assessment and driving simulator task. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with young-onset dementia, i.e. onset of dementia before the age of 65 years.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (9 listed)
- All subjects
- Suffering from severe motion sickness; motion sickness is a risk factor for simulator sickness
- Presence of premorbid severe neurological or psychiatric pathology, non-related to dementia.
- Presence of serious psychiatric disorders or other neurological comorbidities.
- Presence of serious psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological assessment, driving simulator taskNeuropsychological assessment consisting of test measuring general cognitive abilities and social cognition. Driving simulator task measuring risk-taking. | Other | Healthy controls, Patients with frontal brain damage, bvYOD, non-bvYOD |
Primary outcome
Social cognitive performance
Time frame: 2024-2027
Social cognition in bvYOD, compared to non-bvYOD, patients with frontal brain injury and healthy controls
1 secondary outcome
Association between social cognition and risky decision-making
Time frame: 2024-2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Derived from this study: PubMed 40424326Gelmers 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Young-onset Dementia, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gelmers (+31 50 361 46 64, f.gelmers@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social cognitive performance (time frame: 2024-2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06286293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.