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

Recruiting

• Conditions: Alzheimer Disease
• Interventions: Diagnostic Test: Tear Fluid collection (Schirmer's strip); Diagnostic Test: Retinal imaging

• Registration Number: NCT05655793
• Lead Sponsor: Maastricht University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-09
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-19
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Without Neurodegeneration	Tear Fluid collection (Schirmer's strip)	Includes healthy controls and patients with subjective cognitive decline
With Neurodegeneration	Tear Fluid collection (Schirmer's strip)	Includes patients with mild cognitive impairment and dementia
With Neurodegeneration	Retinal imaging	Includes patients with mild cognitive impairment and dementia
Without Neurodegeneration	Retinal imaging	Includes healthy controls and patients with subjective cognitive decline

Primary Outcome Measures

Name	Time	Method
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.	Levels of tear biomarkers will be determined from the Schirmer's strips. The biomarker levels will be analysed to see whether they can be discriminate between people with and without neurodegeneration.

Secondary Outcome Measures

Name	Time	Method
Correlation of biomarker levels in tears, blood and cerebral spinal fluid (CSF).	Baseline measurements (t=0) will be used to determine correlation.	This analysis will be done to determine the correlation between biomarkers of different body fluids.
The difference in tear biomarker level between patients and controls, and between patient groups and how these differences change over time.	Sampling done at t= 0, 1 and 2 years.	Additional analysis to see whether tear biomarkers can also discriminate patients from controls and differences inbetween patient groups.
Correlation between tear biomarkers and other ocular imaging biomarkers, as well as assessing the change of this correlation over time.	Imaging done at t= 0, 1 and 2 years.	The correlation between tear biomarkers and ocular imaging biomarkers (e.g. thickness of the retinal nerve fiber layer, retinal vasculature tortuosity) will be analysed.

Trial Locations

Locations (2)

Academic Hospital Maastricht; 🇳🇱 Maastricht, Limburg, Netherlands

Amsterdam University Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands