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Clinical Trials/NCT02899403
NCT02899403
Unknown
Not Applicable

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

University Hospital, Lille1 site in 1 country20 target enrollmentMay 19, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
University Hospital, Lille
Enrollment
20
Locations
1
Primary Endpoint
EEG spectral power during RVIP task as compared to resting state
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 19, 2017
End Date
December 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
University Hospital, Lille
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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 Outcomes

  • PRM number of errors(within 7 days after inclusion ( session1) and within 7 days after session 1 (=session2))
  • EEG spectral power during PRM task as compared to resting state(within 7 days after inclusion ( session1))
  • difference between session 2 and session 1 EEG Spectral power during RVIP task(at 7 days after session 1)
  • RVIP latency of responses(within 7 days after inclusion ( session1) and within 7days after session 1 (=session2))
  • PRM latency of responses(within 7 days after inclusion (=session1) and within 7 days after session 1 (=session2))

Study Sites (1)

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