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

• ClinicalTrials.gov Identifier: NCT02899403
• Recruitment Status: Unknown
• First Posted: September 14, 2016
• Last Update Posted: June 26, 2019
• Sponsor: University Hospital, Lille
• Information provided by (Responsible Party): University Hospital, Lille

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Alzheimer Disease; ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)	Other: Rapid Visual Information Processing (RVIP) test	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -A Pilot Study WP3 P003
• Actual Study Start Date: May 19, 2017
• Estimated Primary Completion Date: December 2020
• Estimated Study Completion Date: December 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: healthy subjects	Other: Rapid Visual Information Processing (RVIP) test; Rapid Visual Information Processing is a measure of sustained attention.

Outcome Measures

Primary Outcome Measures :

1. EEG spectral power during RVIP task as compared to resting state [ Time Frame: within 7 days after inclusion ( session1) ]
   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

Secondary Outcome Measures :

1. EEG spectral power during PRM task as compared to resting state [ Time Frame: within 7 days after inclusion ( session1) ]
   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
2. RVIP latency of responses [ Time Frame: within 7 days after inclusion ( session1) and within 7days after session 1 (=session2) ]
3. PRM number of errors [ Time Frame: within 7 days after inclusion ( session1) and within 7 days after session 1 (=session2) ]
4. PRM latency of responses [ Time Frame: within 7 days after inclusion (=session1) and within 7 days after session 1 (=session2) ]
5. difference between session 2 and session 1 EEG Spectral power during RVIP task [ Time Frame: at 7 days after session 1 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 30 Years (Adult)
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Contacts

Contact: Régis Bordet, MD,PhD; 3.20.44.54.49 ext +33; regis.bordet@univ-lille2.fr

Locations

France

Hôpital Cardiologique, CIC; Recruiting

Lille, France

Principal Investigator: Dominique Deplanque, MD,PhD

Sponsors and Collaborators

University Hospital, Lille

Investigators

• Principal Investigator: Dominique Deplanque, MD, PhD; University Hospital, Lille

More Information

• Responsible Party: University Hospital, Lille
• ClinicalTrials.gov Identifier: NCT02899403
• Other Study ID Numbers: 2013_45; 2015-A00046-43 ( Other Identifier: ID-RCB number, ANSM )
• First Posted: September 14, 2016
• Last Update Posted: June 26, 2019
• Last Verified: June 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:

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

Additional relevant MeSH terms:

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