RecruitingNot ApplicableNCT06661564

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

Identification de Biomarqueurs Diagnostiques Dans Les Larmes de Patients Atteints de Maladie d'Alzheimer : l'étude Pilote COG-EYE


Sponsor

University Hospital, Tours

Enrollment

90 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The diagnosis of Alzheimer's disease (AD) relies on the detection of protein biomarkers, particularly in cerebrospinal fluid (e.g., Aβ 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 systemic and neurodegenerative diseases, such as amyotrophic lateral sclerosis. This supports the relevance of comparing both AD proteins biomarkers and metabo-lipidomic signatures in the tears of patients with AD (Mild Cognitive Impairement (MCI) and dementia) with healthy controls.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot study (COG-EYE) explores whether proteins found in tears can serve as biomarkers to help diagnose Alzheimer's disease. Tear samples are collected non-invasively and compared between people with and without Alzheimer's. **You may be eligible if...** - You are 18 or older - You are affiliated with the French social security system - You are able to provide informed written consent **You may NOT be eligible if...** - You are pregnant or breastfeeding - You are under legal protection (guardianship or curatorship) - You have another neurodegenerative disease (besides Alzheimer's) - You use eye drops or other treatments that affect tear production - You have worn contact lenses in the past 3 months - You had eye surgery in the past 3 months - You have an eye condition (other than needing glasses) or a disease with eye involvement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERBasal tear collection for the analysis of metabo-lipidomic profiles and concentrations of protein biomarkers (Tau, phosphorylated Tau, Aβ 1-40, and Aβ 1-42)

Collection of a tear volume of (i) 2 x 5µL using glass microcapillary tubes and (ii) 12µL using Schirmer strips after the instillation of anesthetic eye drops for metabo-lipidomic analysis and multiplexing of protein markers

OTHERCollection of a blood sample (5 mL) for blood biomarkers analysis

Collection of a blood sample (5 mL) for blood biomarkers analysis.


Locations(1)

CHRU de Tours

Tours, France, France

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NCT06661564


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