Validation of a new test for social-cognitive functioning
Social-cognitive Functioning: Validation of a New Neuropsychological Test and Prediction of Social Behavioural Disorders in Daily Life
NA · Assistance Publique - Hôpitaux de Paris · NCT05558709
The REALSoCog game-like test will be tried to see if it detects social-cognitive problems in people with Alzheimer's disease, Lewy body dementia, or frontotemporal degeneration.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT05558709 on ClinicalTrials.gov |
What this trial studies
REALSoCog is a novel serious-game neuropsychological task designed to reveal social-cognitive and social behavioral disturbances that may not be evident during routine clinic visits. In this study, patients with Alzheimer's disease, Lewy body dementia, or frontotemporal degeneration will complete REALSoCog alongside standard cognitive batteries (e.g., BCS) and caregiver-report questionnaires. Caregiver input and normative data will be used to compare performance and to calculate sensitivity and specificity for detecting social-cognitive deficits. The protocol targets adults aged 18–90 with MMSE ≥20 and excludes those with major sensory or psychiatric comorbidities to document socio-cognitive profiles across these diseases.
Who should consider this trial
Good fit: Adults aged 18–90 with a clinical diagnosis of Alzheimer's disease, Lewy body dementia, or frontotemporal degeneration who can consent, have MMSE ≥20, and do not have major sensory or psychiatric comorbidities.
Not a fit: People with severe cognitive impairment (MMSE <20), major sensory loss (e.g., blindness or profound deafness), or significant psychiatric/neurological comorbidities are unlikely to benefit from this test.
Why it matters
Potential benefit: If successful, REALSoCog could enable earlier and more accurate detection of social-cognitive problems, helping clinicians tailor care and support for patients and caregivers.
How similar studies have performed: Existing paper-and-pencil social-cognition tests and some game-based approaches have shown value, but REALSoCog is a novel, more ecological tool that still needs validation in these patient groups.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Hôpital de la Pitié-Salpêtrière — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Marc VERNY, Pr — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Marc VERNY, Pr
- Email: marc.verny@aphp.fr
- Phone: 01 42 16 03 12
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Alzheimer's Disease, Lewy Body Dementia, Frontotemporal Degeneration, Neurodegenerative diseases, Social behavior, Social cognition, Neuropsychological assessment