Social-cognitive Functioning: Validation of a New Neuropsychological Test

NCT05558709 | Recruiting

• 1 other identifier: APHP220748
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

Neurodegenerative diseases; Social behavior; Social cognition; Neuropsychological assessment

Outcome Measures

Primary Outcomes (1)

• rate of inappropriate behavioural intentions

  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

  1 hour and a half

Secondary Outcomes (3)

• Assessment of Moral cognition

  1 hour and a half

• Evaluation of Empathy and emotional reactivity

  1 hour and a half

• Assessment of theory of mind

  1 hour and a half

Study Arms (2)

Patients

EXPERIMENTAL

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

Other: REALSOCOG; Other: BCS

Relatives

OTHER

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

Other: Hetero-questionnaires

Interventions

REALSOCOG OTHER

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.

Also known as: neuropsychological test

Patients

BCS OTHER

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.

Also known as: Social-Cognition Battery

Patients

Hetero-questionnaires OTHER

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.

Relatives

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital de la Pitié-Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Lewy Body Disease; Neurodegenerative Diseases; Social Behavior

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Behavior

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• Marc VERNY, Pr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc VERNY, Pr

CONTACT

01 42 16 03 12; marc.verny@aphp.fr

Pauline NARME

CONTACT

06 08 98 38 04; paulinenarme@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 28, 2022
• Study Start: February 4, 2026
• Primary Completion (Estimated): February 4, 2029
• Study Completion (Estimated): February 4, 2030
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

FR (1)