Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06661564

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

Led by University Hospital, Tours · Updated on 2025-10-07

90

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Affiliated with the French Social Security scheme
  • Provided informed and written consent to participate
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Individuals under judicial protection measures
  • Individuals under guardianship or curatorship
  • Diagnosed with other neurodegenerative diseases
  • Use of eye drops or treatments affecting tear production
  • Occasional or permanent contact lens use within the last 3 months
  • Eye surgery within the past 3 months
  • Any ocular pathology other than refractive errors, oculomotor disorders, or amblyopia
  • Any general pathology other than Alzheimer's Disease with ocular implications
  • Inability to perform tear collection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CHRU de Tours

Tours, France, France, 37044

Actively Recruiting

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Research Team

V

Victoire LEROY, MD

CONTACT

R

Raoul Kanav KHANNA, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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