RecruitingNCT05655793

The TearAD Study: Tear Biomarkers for Alzheimer's Disease (AD) Screening and Diagnosis


Sponsor

Maastricht University Medical Center

Enrollment

200 participants

Start Date

Jun 9, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational longitudinal study is to investigates whether tear fluid is a non-invasive source of biomarkers for Alzheimer's disease. The main aim of the study is to evaluate diagnostic accuracy measures (sensitivity and specificity) of tear and retinal biomarkers to discriminate individuals with and without neurodegeneration. Tear fluid from participants will be collected non-invasively with Schirmer's strips, which is a small paper strip placed in the lower eye lid for a maximum of 5 minutes. Additionally, standard, ultra-wide field and cross-sectional retinal images will be obtained.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

The TearAD study explores whether proteins found in tears can be used to screen for or diagnose Alzheimer's disease — potentially offering a simple, non-invasive alternative to brain scans or spinal fluid tests. **You may be eligible if...** - You are over 50 years old - You are either a healthy person with no memory complaints, or someone with memory concerns or a diagnosis being evaluated for Alzheimer's - You have had recent brain imaging (MRI, CT, or PET) or cerebrospinal fluid testing - You have a MMSE (memory test) score of 17 or higher - You are able to come back for follow-up visits over up to 24 months **You may NOT be eligible if...** - You have a serious medical or psychiatric condition that would interfere with participation - You have significant cognitive impairment (MMSE below 17) - You are unable to attend follow-up visits 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

DIAGNOSTIC_TESTTear Fluid collection (Schirmer's strip)

Tear fluid will be collected non-invasively form all participants with the use of Schirmer's strips, which is a small paper strip placed in the lower eye lid for a maximum of 5 minutes.

DIAGNOSTIC_TESTRetinal imaging

The retina from all participants will be visualised with the use of a standard (Clarus 700 Zeiss), ultra-wide field (Optos), and cross-sectional (Optical Coherence Tomography) retinal images.


Locations(2)

Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands

Academic Hospital Maastricht

Maastricht, Limburg, Netherlands

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NCT05655793


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