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

Alzheimer Disease

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

Inclusion Criteria10

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
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 Criteria3

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

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.