Clinical trial NCT05558709: Social-cognitive Functioning: Validation of a New Neuropsychological Test
Official title: Social-cognitive Functioning: Validation of a New Neuropsychological Test and Prediction of Social Behavioural Disorders in Daily Life
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer's Disease (AD)
Lewy Body Dementia (LBD)
Frontotemporal Degeneration (FTD)
Keywords: Neurodegenerative diseases
Social behavior
Social cognition
Neuropsychological assessment
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2022-09-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).

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

Primary outcomes:
measure: rate of inappropriate behavioural intentions
timeFrame: 1 hour and a half
Secondary outcomes:
measure: Assessment of Moral cognition
timeFrame: 1 hour and a half
measure: Evaluation of Empathy and emotional reactivity
timeFrame: 1 hour and a half
measure: Assessment of theory of mind
timeFrame: 1 hour and a half
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital de la Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Marc VERNY, Pr
role: PRINCIPAL_INVESTIGATOR
References: