Using tear fluid to identify Alzheimer's disease
The TearAD Study: Tear Biomarkers for Alzheimer's Disease (AD) Screening and Diagnosis
This study is testing if analyzing tear fluid can help identify Alzheimer's disease in people by comparing it to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 2 sites (Maastricht, Limburg and 1 other locations) |
| Trial ID | NCT05655793 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the potential of tear fluid as a non-invasive source of biomarkers for Alzheimer's disease. Researchers will collect tear samples using Schirmer's strips and obtain retinal images to evaluate the diagnostic accuracy of these biomarkers in distinguishing individuals with neurodegeneration from those without. The study will involve healthy controls and patients, all of whom must have prior neuroimaging data available. Participants will be followed for up to 24 months to assess the effectiveness of these diagnostic methods.
Who should consider this trial
Good fit: Ideal candidates include individuals over 50 years old with available neuroimaging data and a Mini-Mental State Examination (MMSE) score indicating cognitive health.
Not a fit: Patients with ocular conditions that could affect tear biochemical parameters or those with significant cognitive complaints may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a simple and non-invasive method for early screening and diagnosis of Alzheimer's disease.
How similar studies have performed: While the use of tear biomarkers for Alzheimer's is a novel approach, similar studies exploring non-invasive diagnostic methods have shown promise in other conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (healthy controls): * Available CSF, PET, CT or MRI data to evaluate the presence/absence of neurodegeneration (preferably within 1 year of inclusion in this study) * Absence of cognitive complaints or treatment and did not seek help for cognitive complaints in the past * MMSE score 26-30 at baseline * Age \> 50 years * Available for follow-up (up to 24 months) * Written informed consent obtained and documented Inclusion criteria (patients): * Available CSF, PET, CT or MRI data to evaluate the presence/absence of neurodegeneration (preferably within 1 year of inclusion in this study) * Available for follow-up (up to 24 months) * Written informed consent obtained and documented * Capable of giving informed consent themselves (MMSE score \> 17/30) Exclusion Criteria (all subjects): * Ocular conditions that could influence tear biochemical parameters (including eye infection, eye inflammation, eye surgery within the last 28 days or other acute eye conditions) * Neurological or systemic chronic conditions known to interfere with retinal thickness (e.g., glaucoma, diabetes mellitus) * Ocular conditions interfering with optical coherence tomography (OCT) quality/retinal thickness: e.g. severe cataract, age-related macular degeneration, and glaucoma
Where this trial is running
Maastricht, Limburg and 1 other locations
- Academic Hospital Maastricht — Maastricht, Limburg, Netherlands (Recruiting)
- Amsterdam University Medical Center — Amsterdam, Noord-Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Marlies Gijs, PhD — Maastricht University Medical Center
- Study coordinator: Marlies Gijs, PhD
- Email: marlies.gijs@mumc.nl
- Phone: +31 (0)43 3872241
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.