Biomarkers of the Locus Coeruleus Nucleus: Links With Early Tau Pathology, Cognition and Alzheimer's Disease Risk
NCT ID: NCT07007208
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2026-01-01
2029-01-31
Brief Summary
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Detailed Description
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To complete these objectives, the project will evaluate, in healthy older volunteers from the INSPIRE-T cohort (n=100, \> 60 years old), biomarkers of LC neuronal integrity, LC-forebrain connectivity, and LC tonic and phasic activity. Additionally, a positon emission tomography (PET) exam will be conducted using tau-specific tracer. Detailed cognitive assessment will also be performed, including assessment of a priori NA-dependent and NA-independent cognitive functions. In the studied cohort (n = 100), half volunteers will be recruited based on genetic AD risk (APOE4 positive) and the other half based on the absence of risk (APOE4 negative).
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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experimental arm
TEP exam, MRI exam, oculometry assessment and cognitive tasks
a positon emission tomography (PET) exam
TEP exam using tau-specific tracer ( Flortaucipir, unique dose 360 MBq)
MRI Contrast
Data acquisition will include different sequences (anatomical MRI, resting fMRI). The MRI sequences performed will be anatomical imaging (i.e. T1 imaging, FLAIR), a diffusion sequence, a neuromelanin-sensitive sequence and functional imaging at rest (i.e. "the resting state", which allows the functional connectivity within the so-called "default" network to be assessed).
oculometry assessment
Pupillometry and oculometry will be conducted using an EyeBrain medical device (class IIa). Several cognitive tasks will be submitted to the participant, during which the same measurements will be taken. Different stimuli will be presented on the computer screen (visual scenes, text, geometric shapes) during the eye tracking measurement, and an instruction (cognitive task, such as semantic categorization, free exploration of the gaze, reading, saccade execution) will be associated with each type of stimulus. The successive stimuli will be spaced more than 7 secondes apart in order to allow the pupillary response to the first stimulus to be recorded and then to return to the basal diameter before presentation of the next stimulus.
cognitive exams
Cognitive measures will be acquired during an evaluation session through 6 interactive cognitive exercises. These exercises are developed using tools offered by Covirtua Healthcare.
Interventions
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a positon emission tomography (PET) exam
TEP exam using tau-specific tracer ( Flortaucipir, unique dose 360 MBq)
MRI Contrast
Data acquisition will include different sequences (anatomical MRI, resting fMRI). The MRI sequences performed will be anatomical imaging (i.e. T1 imaging, FLAIR), a diffusion sequence, a neuromelanin-sensitive sequence and functional imaging at rest (i.e. "the resting state", which allows the functional connectivity within the so-called "default" network to be assessed).
oculometry assessment
Pupillometry and oculometry will be conducted using an EyeBrain medical device (class IIa). Several cognitive tasks will be submitted to the participant, during which the same measurements will be taken. Different stimuli will be presented on the computer screen (visual scenes, text, geometric shapes) during the eye tracking measurement, and an instruction (cognitive task, such as semantic categorization, free exploration of the gaze, reading, saccade execution) will be associated with each type of stimulus. The successive stimuli will be spaced more than 7 secondes apart in order to allow the pupillary response to the first stimulus to be recorded and then to return to the basal diameter before presentation of the next stimulus.
cognitive exams
Cognitive measures will be acquired during an evaluation session through 6 interactive cognitive exercises. These exercises are developed using tools offered by Covirtua Healthcare.
Eligibility Criteria
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Inclusion Criteria
* Normal cognitive assessment
* MMSE score ≥ 27 out of 30 (Mini-Mental State Examination)
* Normal visual abilities (in corrected or uncorrected vision)
* Normal motor skills
Exclusion Criteria
* Subjects with a known allergic reaction to the PET radiopharmaceutical (\[18F\] Flortaucipir) or any of its excipients
* Subjects with an ophthalmological pathology making oculometric measurements difficult
* Subjects with neurological or psychiatric pathologies
60 Years
100 Years
ALL
Yes
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Locations
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University Hospital of Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-507668-38-00
Identifier Type: CTIS
Identifier Source: secondary_id
RC31/23/0371
Identifier Type: -
Identifier Source: org_study_id