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Life sciences · Observational Study
ClinicalTrials.gov · October 20, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT05655793). This is a study registration, not published results. Lead sponsor: Maastricht University Medical Center. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 200 participants (ACTUAL). Conditions: Alzheimer Disease. Interventions: DIAGNOSTIC_TEST: Tear Fluid collection (Schirmer's strip); DIAGNOSTIC_TEST: Retinal imaging. Primary outcome measures: Capability of tear biomarkers to discriminate individuals with neurodegeneration from those without neurodegeneration and assess the change in biomarker levels over time. , Sampling done at t= 0, 1 and 2 years.. Brief 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.