Social & Affective Cognition as Determinant of Social Behavior in Alzheimer's Disease & Associated Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Correlation coefficient between the mini Social cognition & Emotional Assessment - mini-SEA - total score and the Social Behavior Observer Checklist - SBOC - score in all participants.
研究概览
简要总结
Recent studies have shown that individual neuropsychological scores of patients with Alzheimer's disease and Associated Disorders (ADAD) are only poorly correlated to their behavioral difficulties, such as disinhibition, apathy, social decision-making or vulnerability. Recently, social & affective cognitive disorders have been highlighted as potential cause of social behavioral abnormalities. However, no previous studies have assessed the specific relationship between social & affective cognition & social behavior in ADAD. Our pilot study aims to explore the correlations between core and extended social & affective cognitive processes and social behavior as observed during the neuropsychological examination, as well as to explore the common brain regions involved in those domains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women;
- •40 to 85 years of age (included);
- •Registered with the French Social Security;
- •Have a study partner. The study partner is required to complete several scales. If the subjects or their study partners are not able to drive, their transport fees will be reimbursed by the promotor.
- •Fluent in French, able to read and write;
排除标准
- •Participants who have contraindications to perform an MRI scan;
- •Participants with significant sensory deficits that are not corrected by suitable devices.
- •Participants with dementia caused by a non-neurodegenerative disease, including patients with severe cerebrovascular risk factor load, in the judgment of the investigator;
- •Participants with other neurodegenerative disease such as Lewy body dementia and Parkinson's disease;
- •Participants with other serious neurological disorder such as brain tumor, stroke, epilepsy, hydrocephalus and any condition which contraindicates, in the investigator's judgment, entry to the study;
- •Participants with excessive alcohol intake or drug abuse, in the judgment of the investigator;
- •Participants who, in the opinion of the investigator, have a risk of non-compliance to the study procedures;
结局指标
主要结局
Correlation coefficient between the mini Social cognition & Emotional Assessment - mini-SEA - total score and the Social Behavior Observer Checklist - SBOC - score in all participants.
时间窗: 1day
次要结局
- Correlation coefficients between the mini Social cognition & Emotional Assessment - mini-SEA - sub scores and the neuropsychological assessment (as measured by the Social Behavior Observer Checklist - SBOC - score in all participants.(1 day)
- Correlation coefficient between the SBOC score with MRI markers in all participants(1 day)
- Correlation coefficients between mini-SEA sub scores with the SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.(1 day)
- Correlation coefficients between SCANN sub-scores and the SBOC, SOCIAL50, CBI, ZBS, CSDC, SVS scales in each ADAD and controls groups.(1 day)
- Correlation coefficient between mini-SEA sub scores & MRI markers in all participants.(1 day)