Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -WP3 P003 (PharmacogWP3)

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

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.

Study Overview

• Status: Unknown
• Conditions: Alzheimer Disease; ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)
• Intervention / Treatment: Other: Rapid Visual Information Processing (RVIP) test

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Régis Bordet, MD,PhD; Phone Number: +33 3.20.44.54.49; Email: regis.bordet@univ-lille2.fr

Study Locations

• France
  • Lille, France
    • Recruiting
    • Hôpital Cardiologique, CIC
    • Principal Investigator: Dominique Deplanque, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: healthy subjects	Other: Rapid Visual Information Processing (RVIP) test; Rapid Visual Information Processing is a measure of sustained attention.

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 19, 2017
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: September 1, 2016
• First Submitted That Met QC Criteria: September 13, 2016
• First Posted (ESTIMATE): September 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 26, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Mild Cognitive Impairment; Healthy Volunteers; Cognitive Tasks; Neurophysiological Correlates
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2013_45; 2015-A00046-43 (OTHER: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No