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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Metacognitive efficiency during facial emotion recognition (Mratio)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Computer-based facial expression recognition task (Behavioral)
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).
干预措施: Computerized affective task (Behavioral)
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).
干预措施: UCLA Structured Insight Interview (Behavioral)
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).
干预措施: Barber's Standardized Suggestibility Scale (Behavioral)
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).
干预措施: Computer-based facial expression recognition task (Behavioral)
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).
干预措施: Computerized affective task (Behavioral)
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).
干预措施: UCLA Structured Insight Interview (Behavioral)
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).
干预措施: Barber's Standardized Suggestibility Scale (Behavioral)
结局指标
主要结局
Metacognitive efficiency during facial emotion recognition (Mratio)
时间窗: 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.
次要结局
- 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)
- Effect of feedback on metacognitive adjustment(Day 0, with the second evaluation taking place between Day 1 and Day 20)
- Subjective versus objective metacognitive assessment(Day 0, with the second evaluation taking place between Day 1 and Day 20)
- Impact of anosognosia on social cognition in Alzheimer's disease(Day 0, with the second evaluation taking place between Day 1 and Day 20)
- Association between hypnotic suggestibility and metacognition(A single optional evaluation conducted between Day 1 and Day 20)