Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
Healthy Volunteers
ID05558709

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

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

120

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Disturbances in social cognition are common in neurological conditions and contribute to social conduct disorders, making their assessment vital for early and appropriate care. This research focuses on validating a new serious game test called REALSoCog, designed to better detect social behavior disturbances that might not be obvious during consultations but are often reported by caregivers. The study targets patients with neurodegenerative diseases such as Alzheimer's disease, dementia with Lewy bodies, and fronto-temporal lobar degeneration to evaluate the test's ability to identify social-cognitive issues and document socio-cognitive profiles in these conditions. Participants in this study will perform the REALSoCog task, which involves thinking about 16 social situations within a virtual city environment using a laptop, without extra devices. Patients will also complete social-cognitive tasks from the BCS battery to compare results, while caregivers or relatives will receive questionnaires assessing the patients' social behavior. The study includes both patients with specific neurodegenerative diseases and their relatives who have regular contact with them. During the study, participants will be assessed on various social cognition aspects, including inappropriate behavioral intentions, moral cognition, empathy, emotional reactivity, and theory of mind, with each evaluation lasting about one and a half hours. Caregivers will provide information through questionnaires to validate the test further. The study runs from February 2026 to February 2030 and aims to improve understanding of social cognition disturbances and their relation to individual factors like mood and social participation.

CONDITIONS

Brief 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...

  • Patients aged between 18 and 90 years
  • Mini Mental State Examination (MMSE) score greater than or equal to 20
  • Patients able to give informed and autonomous consent
  • Patients diagnosed with fronto-temporal lobar degeneration, Alzheimer's disease, or dementia with Lewy bodies
  • Caregivers over 18 years old
  • Caregivers having regular contact with the patient at least twice per month
Not Eligible

You will not qualify if you...

  • Patients with neurological or psychiatric comorbidities
  • Patients with significant sensory disorders that interfere with the study, such as profound deafness, age-related macular degeneration, or blindness
  • Patients who oppose participation in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Assessment

Duration - Single session lasting approximately 4.5 hours

Participants perform social-cognitive tasks including the REALSoCog serious game, paper-and-pencil tasks from the BCS battery, and caregivers complete questionnaires about patients' social behavior to evaluate social cognition and behavioral disorders.

1 visit (in-person)

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

P

Pauline NARME

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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