Neurophysiological Correlates of Cognitive Tasks in Healt... | NCT02899403

Studies
Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -WP3 P003

NCT02899403

Sponsor

University Hospital, Lille

Status

Terminated

Last Update Posted

May 22, 2026Actual

Enrollment

6Actual

Phase

Not Applicable

Conditions

Alzheimer Disease
ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)

Interventions

Rapid Visual Information Processing (RVIP) test

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2015-A00046-43	Other Identifier	ID-RCB number, ANSM

Status Module

Record Verification Date

May 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

sponsor decision COVID

Expanded Access Info

Start Date

May 19, 2017Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Dec 31, 2020Actual

First Submitted Date

Sep 1, 2016

First Submission Date that Met QC Criteria

Sep 13, 2016

First Posted Date

Sep 14, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 21, 2026

Last Update Posted Date

May 22, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy subjects	Experimental		Other: Rapid Visual Information Processing (RVIP) test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rapid Visual Information Processing (RVIP) test	Other	Rapid Visual Information Processing is a measure of sustained attention.	healthy subjects

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Dominique Deplanque, MD, PhD	University Hospital, Lille	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided