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NCT Number: NCT07531732

Links Between Self-awareness and Sociocognitive Processes in Neurodegenerative Diseases

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.

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Key information

Conditions

Frontotemporal Dementia, Behavioral Variant Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Frontotemporal Dementia Frontotemporal Lobar Degeneration Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pick Disease of the Brain Tauopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cognitive Neurology Center, Lariboisière-Fernand Widal Hospital Group, APHP

Paris, 75010, France

Location status: Recruiting

Location contact

Emmanuel Cognat, MD PhD

CONTACT

[email protected]

+33 (0) 1 40 05 49 54

About this study

Self-awareness impairments are common in neurodegenerative diseases, yet their relationship with social cognition remains poorly understood. This study aims to characterize metacognitive processes associated with social cognition in bvFTD and AD, and to determine whether these processes differ across diagnostic groups.

The primary objective is to evaluate metacognitive efficiency during a facial emotion recognition task using trial-by-trial retrospective confidence judgments, allowing computation of Mratio. This index reflects the alignment between perceived and actual performance.

Secondary objectives include: (1) assessing additional metacognitive measures (prospective and global judgments), (2) comparing metacognition between bvFTD and AD, (3) examining correlations between metacognitive judgments and social cognitive performance, (4) testing domain specificity by comparing social cognition and memory, (5) evaluating the effect of task complexity, (6) assessing the impact of performance feedback, (7) comparing subjective versus objective metacognitive assessments, (8) investigating the role of anosognosia in AD, and (9) exploring associations with hypnotic suggestibility.

Participants will attend two visits (~2 hours each). The first visit includes eligibility assessment, sociodemographic data collection, and a computerized emotion recognition task with metacognitive judgments. The second visit includes additional computerized tasks assessing theory of mind and memory, and an optional hypnotic suggestibility assessment.

Statistical analyses will include between-group comparisons using non-parametric tests, within-subject analyses, and exploratory correlational and regression analyses.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-based facial expression recognition task

Behavioral

Eighteen facial photographs from the FACES database (Ebner et al., 2010) were selected, each depicting one of six emotions: joy, sadness, disgust, fear, anger, and neutral. For each face, the patient must identify the emotion being expressed by choosing from six verbal labels displayed on the screen.

Computerized affective task

Behavioral

The task consists of 32 silent black-and-white videos featuring two characters interacting in a social situation, adapted from the Pierre and Marie task (Caillaud et al., 2020). Each video lasts between 8 and 9 seconds and shows one of the two characters experiencing a specific emotion. Patients will be asked to infer the emotion felt by that character. The emotions depicted are either positive or negative and vary in complexity: embarrassment, pride, anger, and surprise (8 videos for each emotion). After each video, the name of an emotion will appear on the screen, and patients will be asked to indicate whether the displayed emotion matches the one felt by the protagonist (half of the options will be congruent and the other half incongruent). The measured variable will be the rate of correct responses.

UCLA Structured Insight Interview

Behavioral

The UCLA Structured Insight Interview (Mendez & Shapira, 2011), translated into French, will be used to quantify anosognosia. This is a structured interview, conducted by the investigator, designed to assess patients' awareness of their symptoms in cases of neurodegenerative disease.

Barber's Standardized Suggestibility Scale

Behavioral

The participant, who must keep their eyes closed throughout the administration of the scale, receives a standardized series of suggestions read aloud by the experimenter in a specific order. These suggestions pertain to motor, sensory, verbal, and mnemonic responses (lowering or raising the arm, clenching the hands, feeling thirsty, speech inhibition, immobility, post-hypnotic response, and amnesia).The scale consists of 8 items and is therefore scored on a scale of 0 to 8 : minimum score 0/8 = no suggestibility; maximum score 8/8 = maximum suggestibility.

Primary outcomes

  1. Metacognitive efficiency during facial emotion recognition (Mratio)

    Time frame: Day 0

    Metacognitive efficiency (Mratio) derived from a computerized facial emotion recognition task with trial-by-trial retrospective confidence judgments. This measure quantifies the correspondence between subjective confidence and objective performance in social cognition.

Secondary outcomes

  1. Prospective and global metacognitive judgments

    Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20.

    Assessment of metacognitive performance using prospective (pre-task) and global (post-task) confidence judgments related to social cognitive tasks.

  2. Between-group differences in metacognitive efficiency

    Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20

    Comparison of metacognitive indices (including Mratio) between bvFTD and Alzheimer's disease groups during social cognition tasks.

  3. Association between metacognition and social cognition performance

    Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20

    Correlation between metacognitive judgments and objective performance on social cognition tasks (emotion recognition and theory of mind).

  4. Domain specificity of metacognition (social cognition vs memory)

    Time frame: A single evaluation conducted between Day 1 and Day 20

    Comparison of metacognitive efficiency indices (Mratio) between social cognition tasks and memory tasks.

  5. Effect of task complexity on metacognitive performance

    Time frame: A single evaluation conducted between Day 1 and Day 20

    Comparison of metacognitive performance across tasks of varying complexity (low-level emotion recognition vs higher-level theory of mind).

  6. Effect of feedback on metacognitive adjustment

    Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20

    Evaluation of changes in metacognitive judgments following feedback on actual performance.

  7. Subjective versus objective metacognitive assessment

    Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20

    Comparison between questionnaire-based (subjective) and task-based (objective) metacognitive measures and their relationship with social cognition.

  8. Impact of anosognosia on social cognition in Alzheimer's disease

    Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20

    Comparison of social cognitive and metacognitive performance between Alzheimer's disease patients with and without anosognosia.

  9. Association between hypnotic suggestibility and metacognition

    Time frame: A single optional evaluation conducted between Day 1 and Day 20

    Exploration of the relationship between hypnotic suggestibility scores and metacognitive performance in bvFTD and AD patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel Cognat, MD PhD

CONTACT

[email protected]

+33 (0) 1 40 05 49 54

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Institut de psychologie
  • Laboratoire Mémoire, Cerveau, Cognition
  • Université Paris Cité

Registry information

Official study title

Study of the Links Between Self-awareness and Sociocognitive Processes in Neurodegenerative Diseases in People With Frontotemporal Lobar Degeneration, Behavioral Variant and Alzheimer's Disease

Acronym: SELFSOC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 15, 2026
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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