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Identification of Diagnosis Biomarkers in the Tears of Alzheimer's Disease Patients: The COG-EYE Pilot Study

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Tours
NCT06661564 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

The diagnosis of Alzheimer's disease (AD) relies on the detection of protein biomarkers, particularly in cerebrospinal fluid (e.g., Aฮฒ and phosphorylated Tau) or through brain imaging. The invasive nature of lumbar puncture and the numerous contraindications have driven the search for early and reliable diagnostic biomarkers for AD. Human tears are an accessible biological fluid that has proven relevant in the biomarker search strategy for both ophthalmological and systemic diseases, especially neurodegenerative conditions. Advances in methods for low-volume analysis have facilitated the identification of tear biomarkers. Total tau has been reported as elevated in the tears of patients with AD compared to controls (n=65). Additionally, metabo-lipidomic analyses offer several advantages (accessibility, non-invasiveness, reproducibility) and also appear promising as a diagnostic tool for

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ18 years * Participant affiliated in French Social Security scheme * Informed and written consent from the participant Exclusion Criteria: * Pregnant or breastfeeding woman * Participant under judicial protection measures * Participant under guardianship or curatorship * Contraindications to participation in the research: Other neurodegenerative disease Any eye drops or treatment that may interfere with tear production Occasional or permanent contact lens use within the last 3 months Eye surgery โ‰ค3 months Any ocular pathology other than refractive errors, oculomotor disorders, amblyopia Any general pathology other than AD with ocular implications -Inability to perform tear collection
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What it tests

  • Basal tear collection for the analysis of metabo-lipidomic profiles and concentrations of protein biomarkers (Tau, phosphorylated Tau, Aฮฒ 1-40, and Aฮฒ 1-42)
  • Collection of a blood sample (5 mL) for blood biomarkers analysis
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Where

1 site
CHRU de Tours
Tours, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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