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Clinical Trials/NCT05558709
NCT05558709
Recruiting
N/A

Social-cognitive Functioning: Validation of a New Neuropsychological Test and Prediction of Social Behavioural Disorders in Daily Life

Assistance Publique - Hôpitaux de Paris1 site in 1 country120 target enrollmentFebruary 4, 2026

Overview

Phase
N/A
Intervention
REALSOCOG
Conditions
Alzheimer's Disease (AD)
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
120
Locations
1
Primary Endpoint
rate of inappropriate behavioural intentions
Status
Recruiting
Last Updated
last month

Overview

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).

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
February 4, 2026
End Date
February 4, 2030
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Arms & Interventions

Patients

Patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL) or fronto-temporal lobar degeneration (FTD))

Intervention: REALSOCOG

Patients

Patients suffering from a neurodegenerative disease (Alzheimer's disease (AD), dementia with Lewy bodies (DCL) or fronto-temporal lobar degeneration (FTD))

Intervention: BCS

Relatives

Caregivers or relatives of included patients, having regular contact with the patient (≥ 2 times per month).

Intervention: Hetero-questionnaires

Outcomes

Primary Outcomes

rate of inappropriate behavioural intentions

Time Frame: 1 hour and a half

It is measured by the REALSoCog task through a question asking the participant to specify his behavioral intention in the case where he would have declared his intention to act in front of the social situation presented. These questions are asked for each social situation presented, i.e. for a total of 16 situations

Secondary Outcomes

  • Evaluation of Empathy and emotional reactivity(1 hour and a half)
  • Assessment of Moral cognition(1 hour and a half)
  • Assessment of theory of mind(1 hour and a half)

Study Sites (1)

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