Links Between Self-awareness and Sociocognitive Processes in Neurodegenerative Diseases

NCT07531732 | Recruiting

• 2 other identifiers: APHP2514242025-A02199-40
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Frontotemporal Dementia, Behavioral Variant; Alzheimer Disease

Keywords

Metacognition; Social cognition; Emotion recognition; Theory of Mind; Neuropsychology; Hypnotic suggestibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Prospective and global metacognitive judgments

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

• Between-group differences in metacognitive efficiency

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

• Association between metacognition and social cognition performance

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

• Domain specificity of metacognition (social cognition vs memory)

  A single evaluation conducted between Day 1 and Day 20

• Effect of task complexity on metacognitive performance

  A single evaluation conducted between Day 1 and Day 20

Study Arms (2)

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; Behavioral: Computerized affective task; Behavioral: UCLA Structured Insight Interview; Behavioral: Barber's Standardized Suggestibility Scale

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; Behavioral: Computerized affective task; Behavioral: UCLA Structured Insight Interview; Behavioral: Barber's Standardized Suggestibility Scale

Interventions

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.

Alzheimer's Disease (AD); Behavioral Variant Frontotemporal Dementia (bvFTD)

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.

Alzheimer's Disease (AD); Behavioral Variant Frontotemporal Dementia (bvFTD)

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.

Alzheimer's Disease (AD); Behavioral Variant Frontotemporal Dementia (bvFTD)

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.

Alzheimer's Disease (AD); Behavioral Variant Frontotemporal Dementia (bvFTD)

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut de psychologie: collaborator
• Université Paris Cité: collaborator
• Laboratoire Mémoire, Cerveau, Cognition: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, 75010, France

RECRUITING

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 21810890 BACKGROUND

MeSH Terms

Conditions

Pick Disease of the Brain; Alzheimer Disease

Condition Hierarchy (Ancestors)

Frontotemporal Dementia; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Central Study Contacts

Emmanuel Cognat, MD PhD

CONTACT

+33 (0) 1 40 05 49 54; emmanuel.cognat@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2026
• First Posted: April 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

FR (1)