Links Between Self-awareness and Sociocognitive Processes in Neurodegenerative Diseases

Official 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

Overview

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.

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.

Interventions

• 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 emoti
• 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 =

Primary outcome measures

• Metacognitive efficiency during facial emotion recognition (Mratio) [Time frame: Day 0]

Secondary outcome measures (9)

• Prospective and global metacognitive judgments [Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20.]
• Between-group differences in metacognitive efficiency [Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20]
• Association between metacognition and social cognition performance [Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20]
• Domain specificity of metacognition (social cognition vs memory) [Time frame: A single evaluation conducted between Day 1 and Day 20]
• Effect of task complexity on metacognitive performance [Time frame: A single evaluation conducted between Day 1 and Day 20]
• Effect of feedback on metacognitive adjustment [Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20]
• Subjective versus objective metacognitive assessment [Time frame: Day 0, with the second evaluation taking place between Day 1 and Day 20]
• 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]
• Association between hypnotic suggestibility and metacognition [Time frame: A single optional evaluation conducted between Day 1 and Day 20]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 1 center

• Cognitive Neurology Center, Lariboisière-Fernand Widal Hospital Group, APHP — Paris

Publications

• 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. PMID 21959203
• 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. PMID 31566290
• 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. PMID 20160315
• 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. PMID 29653606
• 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-Schmi PMID 21810890

Identifiers

NCT: NCT07531732 · APHP251424 · 2025-A02199-40

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗