Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -WP3 P003

NCT02899403 | Unknown

• 2 other identifiers: 2013_452015-A00046-43
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)

Keywords

Cognitive Tasks; Mild Cognitive Impairment; Neurophysiological Correlates; Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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 (5)

• EEG spectral power during PRM task as compared to resting state

  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

Study Arms (1)

healthy subjects

EXPERIMENTAL

Other: Rapid Visual Information Processing (RVIP) test

Interventions

Rapid Visual Information Processing (RVIP) test OTHER

Rapid Visual Information Processing is a measure of sustained attention.

healthy subjects

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Cardiologique, CIC

Lille, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Dominique Deplanque, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Régis Bordet, MD,PhD

CONTACT

3.20.44.54.49; regis.bordet@univ-lille2.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 14, 2016
• Study Start: May 19, 2017
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)