Clinical trial NCT02899403: Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -WP3 P003
Official title: Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -A Pilot Study WP3 P003
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Alzheimer Disease
ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)
Keywords: Cognitive Tasks
Mild Cognitive Impairment
Neurophysiological Correlates
Healthy Volunteers
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: EEG spectral power during RVIP task as compared to resting state
timeFrame: within 7 days after inclusion ( session1)
Secondary outcomes:
measure: EEG spectral power during PRM task as compared to resting state
timeFrame: within 7 days after inclusion ( session1)
measure: RVIP latency of responses
timeFrame: within 7 days after inclusion ( session1) and within 7days after session 1 (=session2)
measure: PRM number of errors
timeFrame: within 7 days after inclusion ( session1) and within 7 days after session 1 (=session2)
measure: PRM latency of responses
timeFrame: within 7 days after inclusion (=session1) and within 7 days after session 1 (=session2)
measure: difference between session 2 and session 1 EEG Spectral power during RVIP task
timeFrame: at 7 days after session 1
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Cardiologique, CIC
Study officials:
affiliation: University Hospital, Lille
name: Dominique Deplanque, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: