Multimodal Markers of Neurodegenerative Disorders at Presymptomatic Stages
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Rate of change of clinical, neurophysiological, anatomical and molecular marker profiles of neurodegenerescence and neuroinflammation in presymptomatic individuals
研究概览
简要总结
NeuroPrems is a prospective, monocentric, longitudinal, not relating to a medicinal product for human use, non-randomized, non-controlled research. The study mainly aims to identify longitudinal changes and events in multimodal markers of neurodegeneration and neuroinflammation during the presymptomatic phases of neurodegenerative diseases.
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
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Rate of change of clinical, neurophysiological, anatomical and molecular marker profiles of neurodegenerescence and neuroinflammation in presymptomatic individuals
时间窗: Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5
Clinical markers will be: neurological and neuropsychological testing, and questionnaires; Neurophysiological markers will link functional brain networks and cognitive processes by using MEG, kinematic or eye movement recordings; Anatomical markers will be: cerebral MRI, glymphatic imaging, PET and skin elasticity; Molecular markers will be: blood, CSF, skin cells, iPSC derived biomarkers, transcriptomic, proteomic and metabolomic signatures
次要结局
- Mean time of onset in genetically presymptomatic individuals(Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5)
- Rate of change in consumption of information issued from Consultations, hospitalizations and medication prescriptions(From Year -10 to Year 10 (annual update))
- Time to loss of autonomy(Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5)
- Rate and mean time to symptomatic conversion/progression(Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5)
- Intra-individual change in trajectory profiles determined by multimodal analysis(Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5)
- Rate of change for each study marker(Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5)
- Rate of change in the self-administered questionnaires(Baseline, Year 1, Year 2, Year 3, Year 4 and Year 5)