Links Between Self-awareness and Sociocognitive Processes in Neurodegenerative Diseases (SELFSOC)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease; Frontotemporal Dementia, Behavioral Variant
• Intervention / Treatment: Behavioral: Computer-based facial expression recognition task; Behavioral: Computerized affective task; Behavioral: UCLA Structured Insight Interview; Behavioral: Barber's Standardized Suggestibility Scale

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 34

Contacts and Locations

• Study Contact: Name: Emmanuel Cognat, MD PhD; Phone Number: +33 (0) 1 40 05 49 54; Email: emmanuel.cognat@aphp.fr

Study Locations

• France
  • Paris, France, 75010
    • Recruiting
    • Cognitive Neurology Center, Lariboisière-Fernand Widal Hospital Group, APHP
    • Contact: Emmanuel Cognat, MD PhD; Phone Number: +33 (0) 1 40 05 49 54; Email: emmanuel.cognat@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients diagnosed with behavioral variant frontotemporal lobar degeneration (bvFTD) or Alzheimer's disease (AD) at a mild to moderate stage.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Behavioral Variant Frontotemporal Dementia (bvFTD); Participants diagnosed with behavioral variant frontotemporal dementia according to established clinical criteria (Rascovsky et al., 2011). Patients are aged 50-80 years with mild to moderate disease severity (MMSE ≥20).	Behavioral: Computer-based facial expression recognition task; 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.; Behavioral: Computerized affective task; 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.; Behavioral: UCLA Structured Insight Interview; 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.; Behavioral: Barber's Standardized Suggestibility Scale; 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.
Alzheimer's Disease (AD); Participants diagnosed with Alzheimer's disease based on biomarker-supported criteria (A+T+; Jack et al., 2018). Patients are aged 50-80 years with mild to moderate disease severity (MMSE ≥20).	Behavioral: Computer-based facial expression recognition task; 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.; Behavioral: Computerized affective task; 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.; Behavioral: UCLA Structured Insight Interview; 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.; Behavioral: Barber's Standardized Suggestibility Scale; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metacognitive efficiency during facial emotion recognition (Mratio)	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.	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prospective and global metacognitive judgments	Assessment of metacognitive performance using prospective (pre-task) and global (post-task) confidence judgments related to social cognitive tasks.	Day 0, with the second evaluation taking place between Day 1 and Day 20.
Between-group differences in metacognitive efficiency	Comparison of metacognitive indices (including Mratio) between bvFTD and Alzheimer's disease groups during social cognition tasks.	Day 0, with the second evaluation taking place between Day 1 and Day 20
Association between metacognition and social cognition performance	Correlation between metacognitive judgments and objective performance on social cognition tasks (emotion recognition and theory of mind).	Day 0, with the second evaluation taking place between Day 1 and Day 20
Domain specificity of metacognition (social cognition vs memory)	Comparison of metacognitive efficiency indices (Mratio) between social cognition tasks and memory tasks.	A single evaluation conducted between Day 1 and Day 20
Effect of task complexity on metacognitive performance	Comparison of metacognitive performance across tasks of varying complexity (low-level emotion recognition vs higher-level theory of mind).	A single evaluation conducted between Day 1 and Day 20
Effect of feedback on metacognitive adjustment	Evaluation of changes in metacognitive judgments following feedback on actual performance.	Day 0, with the second evaluation taking place between Day 1 and Day 20
Subjective versus objective metacognitive assessment	Comparison between questionnaire-based (subjective) and task-based (objective) metacognitive measures and their relationship with social cognition.	Day 0, with the second evaluation taking place between Day 1 and Day 20
Impact of anosognosia on social cognition in Alzheimer's disease	Comparison of social cognitive and metacognitive performance between Alzheimer's disease patients with and without anosognosia.	Day 0, with the second evaluation taking place between Day 1 and Day 20
Association between hypnotic suggestibility and metacognition	Exploration of the relationship between hypnotic suggestibility scores and metacognitive performance in bvFTD and AD patients.	A single optional evaluation conducted between Day 1 and Day 20

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Université Paris Cité; Institut de psychologie; Laboratoire Mémoire, Cerveau, Cognition

Publications and helpful links

General Publications

• Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018.
• Rascovsky K, Hodges JR, Knopman D, Mendez MF, Kramer JH, Neuhaus J, van Swieten JC, Seelaar H, Dopper EG, Onyike CU, Hillis AE, Josephs KA, Boeve BF, Kertesz A, Seeley WW, Rankin KP, Johnson JK, Gorno-Tempini ML, Rosen H, Prioleau-Latham CE, Lee A, Kipps CM, Lillo P, Piguet O, Rohrer JD, Rossor MN, Warren JD, Fox NC, Galasko D, Salmon DP, Black SE, Mesulam M, Weintraub S, Dickerson BC, Diehl-Schmid J, Pasquier F, Deramecourt V, Lebert F, Pijnenburg Y, Chow TW, Manes F, Grafman J, Cappa SF, Freedman M, Grossman M, Miller BL. Sensitivity of revised diagnostic criteria for the behavioural variant of frontotemporal dementia. Brain. 2011 Sep;134(Pt 9):2456-77. doi: 10.1093/brain/awr179. Epub 2011 Aug 2.
• Mendez MF, Shapira JS. Loss of emotional insight in behavioral variant frontotemporal dementia or "frontal anosodiaphoria". Conscious Cogn. 2011 Dec;20(4):1690-6. doi: 10.1016/j.concog.2011.09.005. Epub 2011 Sep 29.
• Caillaud M, Bejanin A, Laisney M, Gagnepain P, Gaubert M, Viard A, Clochon P, de La Sayette V, Allain P, Eustache F, Desgranges B. Influence of emotional complexity on the neural substrates of affective theory of mind. Hum Brain Mapp. 2020 Jan;41(1):139-149. doi: 10.1002/hbm.24794. Epub 2019 Sep 30.
• Ebner NC, Riediger M, Lindenberger U. FACES--a database of facial expressions in young, middle-aged, and older women and men: development and validation. Behav Res Methods. 2010 Feb;42(1):351-62. doi: 10.3758/BRM.42.1.351.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Neuropsychology; Metacognition; Social cognition; Emotion recognition; Theory of Mind; Hypnotic suggestibility
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Frontotemporal Lobar Degeneration; Frontotemporal Dementia; Alzheimer Disease; Pick Disease of the Brain
• Other Study ID Numbers: APHP251424; 2025-A02199-40 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No