search
Back to results

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

Primary Purpose

Alzheimer Disease, ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Rapid Visual Information Processing (RVIP) test
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer Disease focused on measuring Cognitive Tasks, Mild Cognitive Impairment, Neurophysiological Correlates, Healthy Volunteers

Eligibility Criteria

18 Years - 30 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Hôpital Cardiologique, CICRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

healthy subjects

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
RVIP latency of responses
PRM number of errors
PRM latency of responses
difference between session 2 and session 1 EEG Spectral power during RVIP task

Full Information

First Posted
September 1, 2016
Last Updated
June 25, 2019
Sponsor
University Hospital, Lille
search

1. Study Identification

Unique Protocol Identification Number
NCT02899403
Brief Title
Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -WP3 P003
Acronym
PharmacogWP3
Official Title
Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -A Pilot Study WP3 P003
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 19, 2017 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)
Keywords
Cognitive Tasks, Mild Cognitive Impairment, Neurophysiological Correlates, Healthy Volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
healthy subjects
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Rapid Visual Information Processing (RVIP) test
Intervention Description
Rapid Visual Information Processing is a measure of sustained attention.
Primary Outcome Measure Information:
Title
EEG spectral power during RVIP task as compared to resting state
Description
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
Time Frame
within 7 days after inclusion ( session1)
Secondary Outcome Measure Information:
Title
EEG spectral power during PRM task as compared to resting state
Description
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
Time Frame
within 7 days after inclusion ( session1)
Title
RVIP latency of responses
Time Frame
within 7 days after inclusion ( session1) and within 7days after session 1 (=session2)
Title
PRM number of errors
Time Frame
within 7 days after inclusion ( session1) and within 7 days after session 1 (=session2)
Title
PRM latency of responses
Time Frame
within 7 days after inclusion (=session1) and within 7 days after session 1 (=session2)
Title
difference between session 2 and session 1 EEG Spectral power during RVIP task
Time Frame
at 7 days after session 1

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Régis Bordet, MD,PhD
Phone
3.20.44.54.49
Ext
+33
Email
regis.bordet@univ-lille2.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Deplanque, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Cardiologique, CIC
City
Lille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Deplanque, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -WP3 P003

We'll reach out to this number within 24 hrs