Tear-based biomarkers for diagnosing Alzheimer's (COG-EYE pilot)
Identification de Biomarqueurs Diagnostiques Dans Les Larmes de Patients Atteints de Maladie d'Alzheimer : l'étude Pilote COG-EYE
This project will test whether tiny tear samples can reveal protein and lipid markers that help diagnose Alzheimer's disease in adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Tours Academic / other |
| Locations | 1 site (Tours, France) |
| Trial ID | NCT06661564 on ClinicalTrials.gov |
What this trial studies
This pilot collects basal tear samples and a small blood draw from adults with Alzheimer's disease at CHRU de Tours to search for diagnostic markers. Tears will be analyzed using metabo-lipidomic methods and low-volume assays to measure proteins (total tau, phosphorylated tau, Aβ1-40, Aβ1-42) and lipid/metabolite profiles. The protocol excludes people with ocular disease, recent eye surgery, contact lens use, or other conditions that affect tear production and requires informed written consent and French social security affiliation. Findings will be compared to known biomarker patterns to see if tear profiles can distinguish Alzheimer's cases.
Who should consider this trial
Good fit: Adults with Alzheimer's who can give written consent, are covered by the French social security system, and have no ocular conditions or recent eye procedures are ideal candidates.
Not a fit: Patients with other neurodegenerative diseases, active ocular pathology, recent eye surgery or recent contact lens use, pregnant or breastfeeding women, those under legal protection, or anyone unable to provide tear samples are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could provide a simple, non-invasive tear test to help diagnose Alzheimer's earlier and reduce reliance on lumbar puncture or costly imaging.
How similar studies have performed: Previous reports have found elevated total tau in tears of Alzheimer's patients (n=65) and metabo-lipidomic methods have shown promise in other neurodegenerative diseases, but tear-based diagnosis remains exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 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 ≤3 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
Where this trial is running
Tours, France
- CHRU de Tours — Tours, France, France (Recruiting)
Study contacts
- Study coordinator: Victoire LEROY, MD
- Email: victoire.leroy@univ-tours.fr
- Phone: 0247477693
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.