Social-cognitive Functioning: Validation of a New Neuropsychological Test

NCT05558709 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-13

No results posted yet for this 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).

Conditions

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

Interventions

OTHER

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.

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Marc VERNY, Pr · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-04
Primary Completion
2029-02-04
Completion
2030-02-04

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05558709 on ClinicalTrials.gov