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

Официальное название

YOD-RiSoCo: the Role of Social Cognition and Better Identification of Risk-taking Behaviour in Patients with Young-onset Dementia

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Social cognitive performance [Срок оценки: 2024-2027]

Вторичные конечные точки (1)

• Association between social cognition and risky decision-making [Срок оценки: 2024-2027]

Критерии участия

Критерии включения

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).

Критерии исключения

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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06286293 · 18171

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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