NCT05558709: REALSOCOG

Social-cognitive Functioning: Validation of a New Neuropsychological Test

Recruiting now NA Last updated 13 March 2026

What this trial tests

NA trial testing REALSOCOG in Alzheimer's Disease (AD) in 120 participants. Currently enrolling.

Timeline

4 February 2026

Primary endpoint
4 February 2029

4 February 2030

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	120
Start date	4 February 2026
Primary completion	4 February 2029
Estimated completion	4 February 2030
Sites	1 location across France

Drugs / interventions tested

• REALSOCOG
• BCS
• Hetero-questionnaires

Conditions studied

• Alzheimer's Disease (AD) — all drugs for Alzheimer's Disease (AD) →
• Lewy Body Dementia (LBD) — all drugs for Lewy Body Dementia (LBD) →
• Frontotemporal Degeneration (FTD) — all drugs for Frontotemporal Degeneration (FTD) →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

Adults 18 to 90, any sex, with Alzheimer's Disease (AD) or Lewy Body Dementia (LBD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.