Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -WP3 P003

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -A Pilot Study WP3 P003

Conditions
-----------------
Alzheimer Disease, ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)

Intervention / Treatment
-----------------
* Other: Rapid Visual Information Processing (RVIP) test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy subjects<br> | Other: Rapid Visual Information Processing (RVIP) test<br>* Rapid Visual Information Processing is a measure of sustained attention.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG spectral power during RVIP task as compared to resting state | 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 | within 7 days after inclusion ( session1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG spectral power during PRM task as compared to resting state | the Pattern Recognition Memory (PRM®) is a test assessing visual recognition memory, considered as a sensitive measure of medial temporal areas dysfunction. It is a useful tool for assessing patients with MCI and AD | within 7 days after inclusion ( session1) | 
| RVIP latency of responses |  | within 7 days after inclusion ( session1) and within 7days after session 1 (=session2) | 
| PRM number of errors |  | within 7 days after inclusion ( session1) and within 7 days after session 1 (=session2) | 
| PRM latency of responses |  | within 7 days after inclusion (=session1) and within 7 days after session 1 (=session2) | 
| difference between session 2 and session 1 EEG Spectral power during RVIP task |  | at 7 days after session 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive Tasks, Mild Cognitive Impairment, Neurophysiological Correlates, Healthy Volunteers