Social-cognitive Functioning: Validation of a New Neuropsychological Test (REALSOCOG)

Assistance Publique - Hôpitaux de Paris

Status: Not yet enrolling

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

Treatments: Other: REALSOCOG; Other: Hetero-questionnaires; Other: BCS

Study type: Interventional

Funder types: Other

Identifiers

NCT05558709

APHP220748

Details and patient eligibility

About

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).

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Patients

Experimental group

Description:

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

Treatment:

Other: BCS

Other: REALSOCOG

Relatives

Other group

Description:

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

Treatment:

Other: Hetero-questionnaires