NCT05655793Completed
The TearAD Study: Tear Biomarkers for Alzheimer's Disease (AD) Screening and Diagnosis
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 200 (actual)
- First submitted
- 8 Dec 2022
- Start date
- 9 Jun 2022
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Maastricht University Medical Center
- Diseases
- Alzheimer disease
- NCT number
- NCT05655793
What you commit to
- Study type: Observational
- Participants enrolled: 200
- From 9 Jun 2022 to the primary completion date, 1 Jul 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Age
- Ocular conditions interfering with optical coherence tomography (OCT) quality/retinal thickness: e.g. severe cataract, age-related macular degeneration, and glaucoma
Who the study is looking for
- 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)
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam University Medical Center Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
| Academic Hospital Maastricht Coordinator of this site? Confirm its status | Maastricht | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.