Cerebral MRI Markers and Oculomotor Indices in Human Ageing: Potential Predictors of Cognitive Maintenance or Decline
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Imaging contrast between the LC nucleus and the pontine tegmentum region
研究概览
简要总结
This research proposes to investigate physiological and cognitive markers of locus coeruleus (LC) neuronal integrity and function in cognitively-healthy participants over 60 years old. The locus coeruleus is a brainstem nucleus, sole source of noradrenaline for the brain. Tau pathology appears in neurons of this nucleus, which may induce initial cognitive changes. The study aims at relating locus coeruleus markers, assessed with MRI and eye-tracking techniques, with cognitive function.
详细描述
The LC is a small brainstem nucleus, sole source of noradrenaline (NA) to the brain. NA is involved in the physiological arousal response: LC neuronal activity is closely related with pupil dilation, and pupil size is now considered a reliable and easy-access biomarker of LC function. NA-dependent cognitive functions include attention, flexibility and memory, which are selectively impaired with age. Accordingly, LC-NA system dysfunction may occur and contribute to initial cognitive changes during old age.
The study will assess, in cognitively-healthy older volunteers from the INSPIRE cohort (n=100, over 60 years old), MRI and pupillometry markers of LC integrity, LC-forebrain connectivity and LC activity. We aim at investigating the relationship between LC biomarkers and cognitive status. Four experimental visits will be conducted by each participant, every 6 months over an 18-month period. Visits V1 and V4 will include MRI, eye-tracking and detailed cognitive exams. Visits V2 and V3 will include a detailed cognitive exam.
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
- 60 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INSPIRE cohort participant
- •Mini-Mental State Examination score ≥ 27 on 30
- •Access to a web connection from participant's or relative's home and regular use of web surfing
- •Signature of the informed consent
- •Affiliated to a social security scheme
排除标准
- •Any contra-indications to MRI exam
- •Ophthalmic pathology impacting eye-tracking measures
- •Neurological or psychiatric pathology
- •Person under guardianship or curatorship
- •Contraindications to MRI examination:
- •Pacemaker or cardiac defibrillator
- •Implanted material activated by an electrical, magnetic or mechanical system
- •Haemostatic clips for intracerebral aneurysms or carotid arteries
- •Orthopedic implants
- •Claustrophobia
- •Ophthalmological pathologies impacting eye tracking measurements:
- •Age-related macular degeneration
- •Unoperated cataract
研究组 & 干预措施
Experimental
MRI, eye-tracking and cognitive exams will be completed by subjects.
干预措施: cognitive exams (Other)
Experimental
MRI, eye-tracking and cognitive exams will be completed by subjects.
干预措施: MRI (Other)
Experimental
MRI, eye-tracking and cognitive exams will be completed by subjects.
干预措施: eye-tracking (Other)
结局指标
主要结局
Imaging contrast between the LC nucleus and the pontine tegmentum region
时间窗: 18 months
The outcome will be measured with brainstem anatomical MRI (no unit) at visits V1 (immediately after inclusion) and V4 (18 months after inclusion).
次要结局
- Z-score of the LC-forebrain connectivity at rest(18 months)
- Amplitude of the phasic pupil response during completion of cognitive tasks(18 months)
- Latency of saccadic eye movements during completion of cognitive tasks(18 months)
- Amplitude of saccadic eye movements during completion of cognitive tasks(18 months)
- Composite cognitive (executive and memory) score(18 months)
- Levels of blood phospho-Tau(18 months)