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Clinical Trials in France / NCT05558709
Recruiting Not applicable

Social-cognitive Functioning: Validation of a New Neuropsychological Test

NCT05558709 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-02-04
Last updated
2026-03-13

Condition(s) studied

Alzheimer's Disease (AD)Lewy Body Dementia (LBD)Frontotemporal Degeneration (FTD)

Investigational drug(s) / intervention(s)

REALSOCOGBCSHetero-questionnaires

REALSOCOG: Patients will be asked to perform the REALSoCog serious game-type social cognition assessment task developed by the LMC2 laboratory (UR 7536). Their performance will be compared to those of control individuals recruited in parallel (independant clinical study: CER-U, IRB N°: 00012020-115). Participants will be asked to think about 16 social situations (6 control situations and 10 experimental situations) encountered in a virtual environment representing a city. REALSoCog can be used on a laptop computer, without any additional technical device.

BCS: Social-cognitive tasks from the BCS (Ehrlé et al., 2011) will also be offered to patients to test the concurrent validity of REALSoCog. This battery assesses social cognition. It includes paper-and-pencil tasks.

Hetero-questionnaires: Hetero-questionnaires assessing patients' social behavior will be transmitted to their relative or primary caregiver (Godefroy \& le GREFEX, 2008; Gury and Ehrlé, in progress of validation) in order to verify the concurrent validity of REALSoCog. These hetero-questionnaires aim to identify and quantify the presence of social skills and behaviour disorders.

Study 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

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hôpital de la Pitié-Salpêtrière Paris France Recruiting

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05558709 on ClinicalTrials.gov ↗ ← All trials in France