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Tears and eye scans eyed as Alzheimer's screening tool

NCT ID NCT05655793

Diagnosis Sponsor: Maastricht University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 20, 2026 · Last updated Oct 21, 2026 · Updated 1 time

Summary

Researchers are studying whether tear fluid and retinal images can help identify people with Alzheimer's-related neurodegeneration. The study includes adults over 50, both with and without cognitive problems, who already have brain scan or spinal fluid data. Participants give a tear sample using a small paper strip placed under the eyelid for up to five minutes, and they have standard and wide-field retinal imaging. The goal is to see whether these eye-based markers can tell people with neurodegeneration apart from those without it.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
tear fluid collection with Schirmer's strips and retinal imaging
What this could lead to
If it works, this could offer a simple, non-invasive way to help screen for Alzheimer's-related brain changes using tears and eye scans.
What could go wrong
This is an early observational study, so the tear markers may not prove reliable enough to tell people apart. Eye-based tests can also be affected by other conditions and may not match brain changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

200 people

The number who actually took part.

Started

Jun 2022

Finished

Sep 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The patients will be selected from the population that visit the memory clinic and are willing to participate in scientific research.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease

Contacts and locations

Locations

  • Academic Hospital Maastricht

    Maastricht, Limburg, 6229 HX, Netherlands

  • Amsterdam University Medical Center

    Amsterdam, North Holland, 1081 HV, Netherlands

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