NCT04616287已完成不适用
Self in Dementia With Lewy Bodies: a Behavioral and Multimodal Neuroimaging Study
University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2021年1月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Neuropsychological assessment
研究概览
简要总结
The present project aims at exploring different components of Self-consciousness or 'the Self', such as autobiographical memory, self-concept and subjective sense of Self, in dementia with Lewy Bodies (DLB) compared to Alzheimer's disease and to normal ageing. Anatomical substrates will be studied in multimodal imaging, in terms of volume, anatomical and functional connectivity. We expect to find an alteration of the different components of the Self, consecutive to insular dysfunction, a key region within cerebral networks of self-consciousness, which is damaged early in the course of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for all participants:
- •Male or female aged between 60 to 80, at the inclusion visit
- •Right-handed
- •Must be affiliated to a social health insurance protection scheme
- •Must be able both to understand the objectives and risks related to the study and to give a dated and signed informed consent
- •Fluency in French
- •At least 9 years of formal education
- •Inclusion criteria for group of dementia with Lewy bodies:
- •Subject meeting McKeith et al. criteria (2017)
- •Subject with prodromal dementia with Lewy bodies meeting the DSM-V Mild Cognitive Impairment criteria (2013)
- •Subject with prodromal or mild dementia with Lewy bodies with an ≤ 20 MMSE score
- •Availability of a caregiver for the inclusion visit
- •Inclusion criteria for group of Alzheimer disease:
- •Subject meeting Dubois et al. criteria (2014)
- •Subject with prodromal or mild Alzheimer disease with an ≤ 20 MMSE score
- •Availability of a caregiver for the inclusion visit
- •Inclusion criteria for healthy elderly:
- •Subject must be matched with patients in terms of age, gender and educational level
- •Absence of any cognitive complaint
- •Autonomy must be preserved
排除标准
- •Subjects with significant neuropsychiatric comorbidities
- •Abnormal neurological examination
- •Sensory impairment that may significantly interfere with testing
- •Contraindication to MRI
- •Claustrophobia
- •Heavy psychotropic drug treatment
- •Excessive and regular consumption of alcohol
- •Subject in period of exclusion (determined by a previous or ongoing study)
- •Inability to give the subject informed information
- •Subject under judicial protection
- •Subject under tutorship or guardianship
结局指标
主要结局
Neuropsychological assessment
时间窗: months 3
Multimodal brain MRI
时间窗: months 3
次要结局
未报告次要终点
研究者
研究点 (2)
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