AgingPrediCogNCT06058897
Magnetic Resonance Imaging (MRI) and Eye-tracking Predictive Markers of Cognitive Ageing.
A study testing MRI, eye-tracking and cognitive exams in people with Aging, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Aging
- What is being tested?
- MRI, eye-tracking and cognitive exams
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 22 Mar 2024to 22 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral MRI Markers and Oculomotor Indices in Human Ageing: Potential Predictors of Cognitive Maintenance or Decline
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.
- Conditions
- Aging
- Being tested
- MRI, eye-tracking, cognitive exams
- Keywords
- ageing, locus coeruleus, noradrenaline, cognition, memory, MRI, pupillometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
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-trackingOther
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 examsOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | MRI, eye-tracking and cognitive exams will be completed by subjects. Receives: Other: MRI; Other: eye-tracking; Other: cognitive exams |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18 months
Secondary outcomes (6)
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).
Measured: 18 months
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).
Measured: 18 months
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).
Measured: 18 months
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).
Measured: 18 months
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).
Measured: 18 months
Levels of blood phospho-Tau
It will be assessed by single-molecule array (Simoa) technology (picogram/ml)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start22 Mar 2024
- Primary completion22 Mar 2028 (estimated)
- Study completion22 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre PAYOUX, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06058897
- Sponsor's protocol ID
- RC31/22/0357
- Acronym
- PrediCog
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2023
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral MRI Markers and Oculomotor Indices in Human Ageing: Potential Predictors of Cognitive Maintenance or Decline
- ClinicalTrials.gov ID
- NCT06058897
- Acronym / sponsor ID
- PrediCog / RC31/22/0357
- Conditions
- Aging
- Keywords
- ageing, locus coeruleus, noradrenaline, cognition, memory, MRI, pupillometry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 22 Mar 2024 (actual)
- Primary completion
- 22 Mar 2028 (estimated)
- Study completion
- 22 Mar 2028 (estimated)
- First posted
- 28 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: MRI, Other: eye-tracking, Other: cognitive examsMRI, eye-tracking and cognitive exams will be completed by subjects. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (14 listed)
- Any contra-indications to MRI exam
- Ophthalmic pathology impacting eye-tracking measures
- Neurological or psychiatric pathology
- Person under guardianship or curatorship
- Pacemaker or cardiac defibrillator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMRI 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. | Other | Experimental |
| eye-trackingEye 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. | Other | Experimental |
| cognitive examsCognitive 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). | Other | Experimental |
Primary outcome
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).
6 secondary outcomes
Z-score of the LC-forebrain connectivity at rest
Time frame: 18 months
Amplitude of the phasic pupil response during completion of cognitive tasks
Time frame: 18 months
Latency of saccadic eye movements during completion of cognitive tasks
Time frame: 18 months
Amplitude of saccadic eye movements during completion of cognitive tasks
Time frame: 18 months
Composite cognitive (executive and memory) score
Time frame: 18 months
Levels of blood phospho-Tau
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre PAYOUX, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, eye-tracking and cognitive exams in people with Aging, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Imaging contrast between the LC nucleus and the pontine tegmentum region (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.