Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -WP3 P003

NCT ID: NCT02899403

Last Updated: 2019-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-19

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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healthy subjects

Group Type EXPERIMENTAL

Rapid Visual Information Processing (RVIP) test

Intervention Type OTHER

Rapid Visual Information Processing is a measure of sustained attention.

Interventions

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Rapid Visual Information Processing (RVIP) test

Rapid Visual Information Processing is a measure of sustained attention.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominique Deplanque, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Cardiologique, CIC

Lille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Régis Bordet, MD,PhD

Role: CONTACT

3.20.44.54.49 ext. +33

Other Identifiers

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2015-A00046-43

Identifier Type: OTHER

Identifier Source: secondary_id

2013_45

Identifier Type: -

Identifier Source: org_study_id

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