NCT05558709 Social-cognitive Functioning: Validation of a New Neuropsychological Test
| NCT ID | NCT05558709 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Alzheimer's Disease (AD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-02-04 |
| Primary Completion | 2029-02-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-02-04 with a primary completion date of 2029-02-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
It is now established that disturbances in social cognition are frequent in neurology and that they contribute to the development of social conduct disorders. Their assessment is therefore essential, particularly in order to propose early and adapted care. However, this assessment remains limited today. A new serious game-type test, REALSoCog, has been developed to address the shortcomings of current tools and to highlight disturbances in social behaviors. The latter are not always observed in consultation although they are often reported by caregivers. The objective of this research is therefore to validate the REALSoCog task in a pathological population (currently being standardized in the general population: CER-U, IRB N°: 00012020-115). The clinical interest of this task will be tested with a group of patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL), fronto-temporal lobar degeneration (FTD)) in order to assess its sensitivity and specificity in the detection of social-cognitive disturbances, and in particular in terms of social behaviors (detection of social behavioral disorders reported in daily life). The objective is also to document the socio-cognitive profiles in the mentioned diseases thanks to a more ecological test, and to better understand the links between socio-cognitive processes on the one hand, and individual characteristics on the other hand (e.g. mood and social participation).
Eligibility Criteria
Inclusion Criteria: For patients: * Patient aged between 18 and 90 years * Mini Mental State Examination (MMSE) score greater than or equal to 20 * Patient able to express his or her non-opposition to participate in the study in an informed and autonomous manner * Patient with a neurodegenerative pathology: FTD, AD or LBD. For caregivers: * Over 18 years of age * Regular contact with the patient (≥ 2 times per month) Exclusion Criteria: For patients: * Neurological or psychiatric comorbidity * Notable sensory disorders (e.g., profound or total deafness, age-related macular degeneration, blindness, etc.) that may interfere with experimental completion. * Opposition to participation in the study
Contact & Investigator
Marc VERNY, Pr
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT05558709 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Alzheimer's Disease (AD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05558709 currently recruiting?
Yes, NCT05558709 is actively recruiting participants. Contact the research team at marc.verny@aphp.fr for enrollment information.
Where is the NCT05558709 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT05558709 clinical trial?
NCT05558709 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Marc VERNY, Pr at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 120 participants.
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