Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -A Pilot Study WP3 P003
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- EEG spectral power during RVIP task as compared to resting state
研究概览
简要总结
In the perspective to better evaluate the efficacy of new treatment strategies for Alzheimer disease (AD), it appears important to develop experimental paradigms to precisely measure cognitive endpoints/biomarkers that may be used in healthy volunteers as tools to validate drug efficacy profile.
The use of Electroencephalography (EEG) may be, therefore, a good candidate. The purpose of the present study is to use EEG to more precisely explore cognitive processes in healthy subjects, with a particular interest in episodic and working memory functions that are usually altered in both AD and Mild Cognitive Impairment (MCI) as well as to better understand underlying neural mechanisms involved in these processes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Right-handed
- •In good health on the basis of the medical interview (medical history, symptoms), the physical examination and vital signs
- •Non smoker and with no history of drug or alcohol abuse
- •Without chronic treatment
- •With normal hearing and normal vision including color (with correction)
- •French speaker and able to understand the test instructions
- •Has provided written informed consent
- •Able to read and understand the Information Form and comply with the protocol instructions and restrictions
排除标准
- •Cognitive impairment (MoCA < 26)
- •Cognitive complaint (MacNair Scale > 15)
- •History of brain disease (severe brain trauma, stroke, cerebral tumor…) or current cerebral disease
- •Major medical or surgical history
- •Current chronic disease
- •Vascular or metabolic risk factor
- •History or current mental disease or addiction (MINI)
- •Family history of young onset dementia
- •Family history of chronic or severe neurological or mental disease (first degree relatives)
- •In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason
- •Participates to another clinical trial or is still being within a washout period of a previous clinical trial
- •Already exposed to cognitive tests used in this study.
研究组 & 干预措施
healthy subjects
干预措施: Rapid Visual Information Processing (RVIP) test (Other)
结局指标
主要结局
EEG spectral power during RVIP task as compared to resting state
时间窗: within 7 days after inclusion ( session1)
The Rapid Visual Information Processing (RVIP®) is a test of sustained attention and has proved useful in many studies in which drugs are used to help develop a disease model. It is sensitive to dysfunction in the parietal and frontal lobe areas of the brain
次要结局
- PRM number of errors(within 7 days after inclusion ( session1) and within 7 days after session 1 (=session2))
- EEG spectral power during PRM task as compared to resting state(within 7 days after inclusion ( session1))
- difference between session 2 and session 1 EEG Spectral power during RVIP task(at 7 days after session 1)
- RVIP latency of responses(within 7 days after inclusion ( session1) and within 7days after session 1 (=session2))
- PRM latency of responses(within 7 days after inclusion (=session1) and within 7 days after session 1 (=session2))