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

Tracking Information

• First Submitted Date: September 1, 2016
• First Posted Date: September 14, 2016
• Last Update Posted Date: June 26, 2019
• Actual Study Start Date: May 19, 2017
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 13, 2016)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 13, 2016)

• 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
• RVIP latency of responses [ Time Frame: within 7 days after inclusion ( session1) and within 7days after session 1 (=session2) ]
• PRM number of errors [ Time Frame: within 7 days after inclusion ( session1) and within 7 days after session 1 (=session2) ]
• PRM latency of responses [ Time Frame: 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 [ Time Frame: at 7 days after session 1 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -WP3 P003
• Official Title: Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -A Pilot Study WP3 P003

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
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Basic Science

Condition

• Alzheimer Disease
• ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)

Intervention

Other: Rapid Visual Information Processing (RVIP) test

Rapid Visual Information Processing is a measure of sustained attention.

Study Arms

Experimental: healthy subjects

Intervention: Other: Rapid Visual Information Processing (RVIP) test

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 13, 2016): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 30 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02899403
• Other Study ID Numbers: 2013_45; 2015-A00046-43 ( Other Identifier: ID-RCB number, ANSM )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University Hospital, Lille
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Lille
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University Hospital, Lille
• Verification Date: June 2019