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NCT Number: NCT06058897

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

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.

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Key information

Conditions

Aging

Age range

60 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

Toulouse, 31059, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

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.

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.

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).

Primary outcomes

  1. Imaging contrast between the LC nucleus and the pontine tegmentum region

    Time frame: 18 months

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

Secondary outcomes

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

    Time frame: 18 months

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

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

    Time frame: 18 months

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

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

    Time frame: 18 months

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

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

    Time frame: 18 months

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

  5. Composite cognitive (executive and memory) score

    Time frame: 18 months

    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).

  6. Levels of blood phospho-Tau

    Time frame: 18 months

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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Cerebral MRI Markers and Oculomotor Indices in Human Ageing: Potential Predictors of Cognitive Maintenance or Decline

Acronym: PrediCog

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 28, 2023
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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