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NCT Number: NCT05558709

Social-cognitive Functioning: Validation of a New Neuropsychological Test

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).

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Key information

Conditions

Alzheimer's Disease (AD) Alzheimer Disease Basal Ganglia Diseases Behavior Brain Diseases Central Nervous System Diseases Dementia Frontotemporal Degeneration (FTD) Lewy Body Dementia (LBD) Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Social Behavior Synucleinopathies Tauopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital de la Pitié-Salpêtrière

Paris, 75013, France

Location status: Recruiting

Location contact

Marc VERNY, Pr

CONTACT

[email protected]

01 42 16 03 12 ext. +33

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: neuropsychological test

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.

Other names: Social-Cognition Battery

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.

Primary outcomes

  1. 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

  1. Assessment of Moral cognition

    Time frame: 1 hour and a half

    The ability to detect moral transgressions, the ability to detect conventional transgressions, and the ability to detect control situations (non-transgressive situations) are measured by the question "Does this situation seem appropriate or inappropriate to you?" asked after each REALSoCog situation. The severity judgment of moral transgressions and the severity judgment of conventional transgressions are measured by the question "How inappropriate does it [the situation] seem to you?" asked after each response characterizing the situation presented as inappropriate in REALSoCog.

  2. Evaluation of Empathy and emotional reactivity

    Time frame: 1 hour and a half

    The intensity of emotional empathy and the intensity of emotional reactivity are measured by the question "How much are you affected by the situation? This question is asked after each experimental situation of REALSoCog (i.e. situations involving a transgression and situations constructed to elicit empathy), i.e. for 10 situations.

    The valence and congruence of the emotions felt are measured by the question "The emotion you feel at the sight of this situation is: 1 (very negative) to 5 (very positive)". This question is asked after each experimental situation of REALSoCog (i.e. situations involving a transgression and situations constructed to elicit empathy), i.e. for 10 situations.

  3. Assessment of theory of mind

    Time frame: 1 hour and a half

    The ability to detect the intentionality of an action is measured by the question "Is the behavior of the [main protagonist in the situation] intentional? Yes / No". This question is asked for 5 REALSoCog situations.

    The ability to characterize the valence of this intention and the average valence of the attributed intentions is measured by the question "In your opinion the intention is: 1 (very malicious) to 5 (very benevolent)". This question is asked for 5 REALSoCog situations.

    The ability to infer an affect to others is measured by the question "How does [main protagonist of the situation] feel?". This question is asked for 8 REALSoCog situations.

    The intensity of the affect attributed to others is measured by the question "How does [main protagonist of the situation] feel about [subject's response to the previous question]?" This question is asked for 8 REALSoCog situations.

Study contacts

Contact information is provided by the study sponsor or research team.

Marc VERNY, Pr

CONTACT

[email protected]

01 42 16 03 12 ext. +33

Pauline NARME

CONTACT

[email protected]

06 08 98 38 04 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: REALSOCOG

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Sep 28, 2022
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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