NCT07531732 Links Between Self-awareness and Sociocognitive Processes in Neurodegenerative Diseases
| NCT ID | NCT07531732 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Frontotemporal Dementia, Behavioral Variant |
| Study Type | OBSERVATIONAL |
| Enrollment | 34 participants |
| Start Date | 2026-04 |
| Primary Completion | 2027-12 |
Trial Parameters
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Brief Summary
This monocentric, non-interventional study (SELFSOC) investigates the relationship between self-awareness and social cognition in patients with behavioral variant frontotemporal dementia (bvFTD) and Alzheimer's disease (AD). The primary objective is to assess metacognitive efficiency related to social cognitive performance using a computerized facial emotion recognition task combined with confidence judgments. Metacognitive indices (including Mratio) will quantify the correspondence between subjective and objective performance. Thirty-four participants (17 bvFTD, 17 AD; age 50-80; MMSE ≥20) will complete two study visits involving tasks assessing emotion recognition, theory of mind, and memory.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of possible or probable behavioral variant frontotemporal dementia according to the Rascovsky 2011 criteria (DLFTvc group) OR * Diagnosis of Alzheimer's disease according to the Jack 2018 criteria, including biomarkers (MA group) * Mini-Mental State Examination (MMSE) ≥ 20 * Age: 50-80 years * Sufficient reading and writing proficiency in French to enable completion of the study procedures, in the investigator's opinion Exclusion Criteria: * Moderate to severe language disorders: Confrontation naming (DO 40 scale) ≤ 32 * Inability to perform computerized tasks according to the investigator's opinion * Other neurological disorders (including epilepsy, Lewy body disease, vascular dementia) * Psychiatric comorbidities (bipolar disorder, schizophrenia, current major depressive episode) * Uncorrected visual impairment