NCT05655793

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Maastricht University Medical Center · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Tear 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_TEST	Retinal 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.

Timeline

• Start date: 2022-06-09
• Primary completion: 2025-07-01
• Completion: 2025-07-01
• First posted: 2022-12-19
• Last updated: 2024-03-13

Locations

2 sites across 1 country: Netherlands