Links Between Self-awareness and Sociocognitive Processes in Neurodegenerative Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-80
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial population
Adult patients diagnosed with behavioral variant frontotemporal lobar degeneration (bvFTD) or Alzheimer's disease (AD) at a mild to moderate stage.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Computer-based facial expression recognition task
BehavioralEighteen 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
BehavioralThe 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
BehavioralThe 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
BehavioralThe 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.
Treatment groups
34 Participants
are divided into 2 treatment groupsGroup A: Behavioral Variant Frontotemporal Dementia (bvFTD)4 interventions
Group B: Alzheimer's Disease (AD)4 interventions
Trial outcomes
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.
Time frame
Day 0Secondary outcomes
1
Prospective and global metacognitive judgments
Assessment of metacognitive performance using prospective (pre-task) and global (post-task) confidence judgments related to social cognitive tasks.
Time frame
Day 0, with the second evaluation taking place between Day 1 and Day 20.2
Between-group differences in metacognitive efficiency
Comparison of metacognitive indices (including Mratio) between bvFTD and Alzheimer's disease groups during social cognition tasks.
Time frame
Day 0, with the second evaluation taking place between Day 1 and Day 203
Association between metacognition and social cognition performance
Correlation between metacognitive judgments and objective performance on social cognition tasks (emotion recognition and theory of mind).
Time frame
Day 0, with the second evaluation taking place between Day 1 and Day 204
Domain specificity of metacognition (social cognition vs memory)
Comparison of metacognitive efficiency indices (Mratio) between social cognition tasks and memory tasks.
Time frame
A single evaluation conducted between Day 1 and Day 20Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Assistance Publique - Hôpitaux de Paris
Lead sponsor
Institut de psychologie
Collaborator
Université Paris Cité
Collaborator
Laboratoire Mémoire, Cerveau, Cognition
Collaborator
Source ClinicalTrials.gov