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Biomarkers of the locus coeruleus nucleus: links with early tau pathology, cognition and AD risk. LocusTau

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507668-38-00
Acronym
RC31/23-0371
Enrollment
100
Registered
2024-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer’s Disease

Brief summary

diagnostic capabilities (sensitivity, specificity and AUC) of oculometry (pupillary response, number, latency and amplitude of ocular saccades), functional MRI (LC-hippocampus and LC-prefrontal cortex) and structural MRI (LC intensity) for a positive PET-Tau exam.

Detailed description

The diagnostic capabilities (sensitivity, specificity and AUC) of each of the elements of oculometry (pupillary response, number, latency and amplitude of ocular saccades), functional MRI (LC-hippocampus and LC-prefrontal cortex) and structural MRI (LC intensity) for a positive PET-Tau examination will be evaluated separately for the APOe4- and APOe4+ groups, The relationship between different LC biomarkers (PET, MRI, pupillometry)., The reliability of pupillometry and oculometry measurements will be validated by retesting a subgroup of 30 participants 1 to 4 weeks apart., The link between PET Tau uptake and changes at 12 and 24 months in pupillometry, oculometry and the structural (neuromelanin) and functional integrity of the LC measured on MRI will be assessed by correlating variations expressed as absolute values or as a proportion of the baseline value with PET Tau, and by regression., The link between variations in pupillometry, oculometry and the structural (neuromelanin) and functional integrity of the LC measured on MRI at 12 and 24 months will be evaluated by correlation between variations expressed as absolute values or as a proportion of the baseline value and by regression, The relationship between the various LC biomarkers (PET, MRI, pupillometry) and participants' cognitive performance will be assessed both at inclusion and at 12 and 24 months, using regressions that take into account age, gender, level of education and APOe4 status., All items will be compared between APOe4+ and APOe4- groups.a) Structural (neuromelanin) and functional integrity of the LC measured by MRI. b) Cognitive performance. c) Pupillometry and oculometry. d) And their evolution at 12 and 24 months.

Interventions

Sponsors

Centre Hospitalier Universitaire De Toulouse
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
diagnostic capabilities (sensitivity, specificity and AUC) of oculometry (pupillary response, number, latency and amplitude of ocular saccades), functional MRI (LC-hippocampus and LC-prefrontal cortex) and structural MRI (LC intensity) for a positive PET-Tau exam.

Secondary

MeasureTime frame
The diagnostic capabilities (sensitivity, specificity and AUC) of each of the elements of oculometry (pupillary response, number, latency and amplitude of ocular saccades), functional MRI (LC-hippocampus and LC-prefrontal cortex) and structural MRI (LC intensity) for a positive PET-Tau examination will be evaluated separately for the APOe4- and APOe4+ groups, The relationship between different LC biomarkers (PET, MRI, pupillometry)., The reliability of pupillometry and oculometry measurements will be validated by retesting a subgroup of 30 participants 1 to 4 weeks apart., The link between PET Tau uptake and changes at 12 and 24 months in pupillometry, oculometry and the structural (neuromelanin) and functional integrity of the LC measured on MRI will be assessed by correlating variations expressed as absolute values or as a proportion of the baseline value with PET Tau, and by regression., The link between variations in pupillometry, oculometry and the structural (neuromelanin) and fu

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026