Neurophysiological Correlates of Cognitive Tasks in Healthy Volunteers -WP3 P003

Alzheimer Disease Clinical Trial

— PharmacogWP3  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02899403
• Other study ID #: 2013_45
• Secondary ID: 2015-A00046-43
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2017
• Est. completion date: December 2020

Study information

• Verified date: June 2019
• Source: University Hospital, Lille
• Contact: Régis Bordet, MD,PhD
• Phone: 3.20.44.54.49
• Email: regis.bordet[@]univ-lille2.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• 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.

Locations

Country	Name	City	State
France	Hôpital Cardiologique, CIC	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	RVIP latency of responses		within 7 days after inclusion ( session1) and within 7days after session 1 (=session2)
Secondary	PRM number of errors		within 7 days after inclusion ( session1) and within 7 days after session 1 (=session2)
Secondary	PRM latency of responses		within 7 days after inclusion (=session1) and within 7 days after session 1 (=session2)
Secondary	difference between session 2 and session 1 EEG Spectral power during RVIP task		at 7 days after session 1