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

Launched by MAASTRICHT UNIVERSITY MEDICAL CENTER · Dec 16, 2022

Keywords

ClinConnect Summary

The TearAD Study is researching whether tear fluid can be used to help diagnose Alzheimer's disease in a simple and non-invasive way. Researchers are looking to see if certain markers found in tears can accurately identify individuals who may have neurodegeneration, which is the gradual loss of nerve cells that can lead to Alzheimer's. To participate, individuals must be over 50 years old and have recent brain scans or tests to confirm their cognitive health. Healthy participants should score between 26 to 30 on a memory test, while patients with Alzheimer's should have a score above 17.

Participants in the study will have small paper strips placed in their lower eyelids for about five minutes to collect tear fluid, and they will also have images taken of their retinas. The study is currently recruiting individuals, and those who join will need to be available for follow-ups over the next two years. It’s important to note that people with certain eye conditions or other chronic illnesses that could affect the results will not be eligible to participate. This study aims to find a new, easier way to detect Alzheimer's disease, which could make a significant difference in how we approach diagnosis and treatment in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria (healthy controls):
• • 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
• Inclusion criteria (patients):
• • 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 Criteria (all subjects):
• • 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

Trial Officials