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NCT05558709 | RECRUITING | Alzheimer's Disease (AD)


Social-cognitive Functioning: Validation of a New Neuropsychological Test
Sponsor:

Public assistance - Paris hospitals

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).

Condition or disease

Alzheimer's Disease (AD)

Lewy Body Dementia (LBD)

Frontotemporal Degeneration (FTD)

Intervention/treatment

REALSOCOG

BCS

Hetero-questionnaires

Phase

NA

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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Social-cognitive Functioning: Validation of a New Neuropsychological Test and Prediction of Social Behavioural Disorders in Daily Life
Actual Study Start Date : 2025-11-28
Estimated Primary Completion Date : 2029-11-28
Estimated Study Completion Date : 2029-11-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
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

Social-cognitive Functioning: Validation of a New Neuropsychological Test

Location Details

NCT05558709


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Locations


RECRUITING

France,

Pitié-Salpêtrière Hospital

Paris, France, 75013

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