Magnetic Resonance Imaging (MRI) and Eye-tracking Predictive Markers of Cognitive Ageing.

NCT06058897 | Recruiting

• 1 other identifier: RC31/22/0357
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This research proposes to investigate physiological and cognitive markers of locus coeruleus (LC) neuronal integrity and function in cognitively-healthy participants over 60 years old. The locus coeruleus is a brainstem nucleus, sole source of noradrenaline for the brain. Tau pathology appears in neurons of this nucleus, which may induce initial cognitive changes. The study aims at relating locus coeruleus markers, assessed with MRI and eye-tracking techniques, with cognitive function.

Conditions

Aging

Keywords

ageing; locus coeruleus; noradrenaline; cognition; memory; MRI; pupillometry

Outcome Measures

Primary Outcomes (1)

• Imaging contrast between the LC nucleus and the pontine tegmentum region

  The outcome will be measured with brainstem anatomical MRI (no unit) at visits V1 (immediately after inclusion) and V4 (18 months after inclusion).

  18 months

Secondary Outcomes (6)

• Z-score of the LC-forebrain connectivity at rest

  18 months

• Amplitude of the phasic pupil response during completion of cognitive tasks

  18 months

• Latency of saccadic eye movements during completion of cognitive tasks

  18 months

• Amplitude of saccadic eye movements during completion of cognitive tasks

  18 months

• Composite cognitive (executive and memory) score

  18 months

Study Arms (1)

Experimental

EXPERIMENTAL

MRI, eye-tracking and cognitive exams will be completed by subjects.

Other: MRI; Other: eye-tracking; Other: cognitive exams

Interventions

cognitive exams OTHER

Cognitive measures will be acquired during an evaluation session through interactive cognitive exercises. These exercises are developed using tools offered by Covirtua Healthcare (Covirtua Cognition software). Some exercises will test cognitive systems a priori dependent on NA release (episodic memory, working memory, selective attention, selective inhibition, planning) and other a priori independent of NA (semantic memory: categorization, naming).

Experimental

MRI OTHER

MRI examinations will be conducted on the 3T MRI technical platform. During the MRI examination, images reflecting the integrity of the LC (quantification of neuromelanin as well as its functional connections with the different brain regions (resting functional MRI) will be acquired. High-resolution T1 and T2 weighted images of the the entire brain will also be acquired for the volumetry of cerebral areas.

Experimental

eye-tracking OTHER

Eye tracking examinations will be conducted using an EyeBrain medical device (class IIa) developed by Suricog. This eye tracker will be installed in a box, in an experimental room. The eye tracker is combined with a computer to present visual cognitive tasks. Pupillary dilation/constriction measurements will be acquired at rest (when fixing a cross presented on the screen) and during the performance of different cognitive tasks (exploration and processing of scenes visuals, reading texts, making saccades or anti-saccades when presenting visual targets). These pupillary measurements will then be linked to the memorization of the stimuli presented, this recognition being tested at the end of the exam.

Experimental

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• INSPIRE cohort participant
• Mini-Mental State Examination score ≥ 27 on 30
• Access to a web connection from participant's or relative's home and regular use of web surfing
• Signature of the informed consent
• Affiliated to a social security scheme

You may not qualify if:

• Any contra-indications to MRI exam
• Ophthalmic pathology impacting eye-tracking measures
• Neurological or psychiatric pathology
• Person under guardianship or curatorship
• Contraindications to MRI examination:
• Pacemaker or cardiac defibrillator
• Implanted material activated by an electrical, magnetic or mechanical system
• Haemostatic clips for intracerebral aneurysms or carotid arteries
• Orthopedic implants
• Claustrophobia
• Ophthalmological pathologies impacting eye tracking measurements:
• Glaucoma
• Age-related macular degeneration
• Unoperated cataract

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital

Toulouse, 31059, France

RECRUITING

Study Officials

• Pierre PAYOUX, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre PAYOUX, MD

CONTACT

0562746169; payoux.p@chu-toulouse.fr

Florence REMY, PhD

CONTACT

05 62 74 61 54; florence.remy@cnrs.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: September 28, 2023
• Study Start: March 22, 2024
• Primary Completion (Estimated): March 22, 2028
• Study Completion (Estimated): March 22, 2028
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

FR (1)