CClinicalTrials.gg
Active, not recruitingNCT06058897PrediCogUpdated Jul 16, 2026

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

An interventional study of MRI and eye-tracking in Aging, sponsored by University Hospital, Toulouse. Active, not recruiting at 1 site in France. Open to participants aged 60 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
60 Years to 100 Years
Sex
All
01

Study 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.

Read the detailed description

The LC is a small brainstem nucleus, sole source of noradrenaline (NA) to the brain. NA is involved in the physiological arousal response: LC neuronal activity is closely related with pupil dilation, and pupil size is now considered a reliable and easy-access biomarker of LC function. NA-dependent cognitive functions include attention, flexibility and memory, which are selectively impaired with age. Accordingly, LC-NA system dysfunction may occur and contribute to initial cognitive changes during old age.

The study will assess, in cognitively-healthy older volunteers from the INSPIRE cohort (n=100, over 60 years old), MRI and pupillometry markers of LC integrity, LC-forebrain connectivity and LC activity. We aim at investigating the relationship between LC biomarkers and cognitive status. Four experimental visits will be conducted by each participant, every 6 months over an 18-month period. Visits V1 and V4 will include MRI, eye-tracking and detailed cognitive exams. Visits V2 and V3 will include a detailed cognitive exam.

02

Conditions studied

  • Aging

Keywords

  • ageing
  • locus coeruleus
  • noradrenaline
  • cognition
  • memory
  • MRI
  • pupillometry
03

In context

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Experimental

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

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

Interventions

  • OtherMRI

    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.

  • Othereye-tracking

    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.

  • Othercognitive exams

    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).

06

What researchers measure

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).

    Time frame: 18 months

Secondary outcomes

  1. Z-score of the LC-forebrain connectivity at rest

    It will be assessed with resting-state functional MRI (no unit) at visits V1 (immediately after inclusion) and V4 (18 months after inclusion).

    Time frame: 18 months

  2. Amplitude of the phasic pupil response during completion of cognitive tasks

    It will be assessed with eye-tracking (in millimeter) at visits V1 (immediately after inclusion) and V4 (18 months after inclusion).

    Time frame: 18 months

  3. Latency of saccadic eye movements during completion of cognitive tasks

    It will be assessed with eye-tracking (in milliseconds) at visits V1 (immediately after inclusion) and V4 (18 months after inclusion).

    Time frame: 18 months

  4. Amplitude of saccadic eye movements during completion of cognitive tasks

    It will be assessed with eye-tracking (in millimeter) at visits V1 (immediately after inclusion) and V4 (18 months after inclusion).

    Time frame: 18 months

  5. Composite cognitive (executive and memory) score

    It will be assessed (no unit) at visits V1 (immediately after inclusion), V2 (6 months after inclusion), V3 (12 months after inclusion) and V4 (18 months after inclusion).

    Time frame: 18 months

  6. Levels of blood phospho-Tau

    It will be assessed by single-molecule array (Simoa) technology (picogram/ml)

    Time frame: 18 months

07

Study locations

1 site
  • University Hospital
    Toulouse, 31059, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06058897
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Sep 28, 2023
Start date
Mar 22, 2024
Primary completion
Mar 22, 2028 (estimated)
Completion
Mar 22, 2028 (estimated)
Last update
Jul 16, 2026

Study contacts

Pierre PAYOUX, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion