Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
NCT05558709

Social-cognitive Functioning: Validation of a New Neuropsychological Test

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-03-13

120

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

Social-cognitive Functioning: Validation of a New Neuropsychological Test

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient aged between 18 and 90 years
  • Mini Mental State Examination (MMSE) score greater than or equal to 20
  • Patient able to give informed and autonomous consent
  • Diagnosis of frontotemporal degeneration, Alzheimer's disease, or Lewy body dementia
  • Caregiver over 18 years old
  • Caregiver has regular contact with patient at least twice per month
Not Eligible

You will not qualify if you...

  • Neurological or psychiatric comorbidity
  • Significant sensory disorders interfering with the study (e.g., profound deafness, blindness)
  • Patient opposes participation in the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hôpital de la Pitié-Salpêtrière

Paris, France, 75013

Actively Recruiting

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Research Team

M

Marc VERNY, Pr

CONTACT

P

Pauline NARME

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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