Alzheimer DiseaseTearADNCT05655793
The TearAD Study: Tear Biomarkers for Alzheimer's Disease (AD) Screening and Diagnosis
An observational study of Alzheimer Disease, run by Maastricht University Medical Center at 2 sites in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Tear Fluid collection (Schirmer's strip) and Retinal imaging
- How many people
- 200 participants
- Where
- 2 sitesNetherlands
- Study dates
- 9 Jun 2022to 10 Sep 2026
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients will be selected from the population that visit the memory clinic and are willing to participate in scientific research.
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Netherlands2 sites
Amsterdam University Medical Center
Amsterdam, North Holland, 1081 HV
Academic Hospital Maastricht
Maastricht, Limburg, 6229 HX
About this study
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.
- Conditions
- Alzheimer Disease
- Being tested
- Tear Fluid collection (Schirmer's strip), Retinal imaging
- Keywords
- Tear Fluid, Retinal imaging, Biomarkers
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tear Fluid collection (Schirmer's strip)Diagnostic test
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.
Retinal imagingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| With Neurodegeneration | Includes patients with mild cognitive impairment and dementia Receives: Diagnostic Test: Tear Fluid collection (Schirmer's strip); Diagnostic Test: Retinal imaging | |
| Without Neurodegeneration | Includes healthy controls and patients with subjective cognitive decline Receives: Diagnostic Test: Tear Fluid collection (Schirmer's strip); Diagnostic Test: Retinal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Capability of tear biomarkers to discriminate individuals with neurodegeneration from those without neurodegeneration and assess the change in biomarker levels over time.
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.
Measured: Sampling done at t= 0, 1 and 2 years.
Secondary outcomes (3)
The difference in tear biomarker level between patients and controls, and between patient groups and how these differences change over time.
Additional analysis to see whether tear biomarkers can also discriminate patients from controls and differences inbetween patient groups.
Measured: Sampling done at t= 0, 1 and 2 years.
Correlation of biomarker levels in tears, blood and cerebral spinal fluid (CSF).
This analysis will be done to determine the correlation between biomarkers of different body fluids.
Measured: Baseline measurements (t=0) will be used to determine correlation.
Correlation between tear biomarkers and other ocular imaging biomarkers, as well as assessing the change of this correlation over time.
The correlation between tear biomarkers and ocular imaging biomarkers (e.g. thickness of the retinal nerve fiber layer, retinal vasculature tortuosity) will be analysed.
Measured: Imaging done at t= 0, 1 and 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start9 Jun 2022
- Primary completion1 Jul 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marlies Gijs, PhD, Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05655793
- Sponsor's protocol ID
- 20-033
- Acronym
- TearAD
- Status last verified
- Oct 2026
- First submitted
- 8 Dec 2022
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van de Sande N, Ramakers IHGB, Visser PJ, Verhey FRJ, Verbraak FD, Bouwman FH, Berendschot TTJM, Nuijts RMMA, Webers CAB, Gijs M. Tear biomarkers for Alzheimer's disease screening and diagnosis (the TearAD study): design and rationale of an observational longitudinal multicenter study. BMC Neurol. 2023 Aug 5;23(1):293. doi: 10.1186/s12883-023-03335-y.
PubMed 37543602
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The TearAD Study: Tear Biomarkers for Alzheimer's Disease (AD) Screening and Diagnosis
- ClinicalTrials.gov ID
- NCT05655793
- Acronym / sponsor ID
- TearAD / 20-033
- Conditions
- Alzheimer Disease
- Keywords
- Tear Fluid, Retinal imaging, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 19 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With Neurodegeneration | – | Diagnostic Test: Tear Fluid collection (Schirmer's strip), Diagnostic Test: Retinal imagingIncludes patients with mild cognitive impairment and dementia |
| Without Neurodegeneration | – | Diagnostic Test: Tear Fluid collection (Schirmer's strip), Diagnostic Test: Retinal imagingIncludes healthy controls and patients with subjective cognitive decline |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be selected from the population that visit the memory clinic and are willing to participate in scientific research.
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tear 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 test | With Neurodegeneration, Without Neurodegeneration |
| Retinal imagingThe 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. | Diagnostic test | With Neurodegeneration, Without Neurodegeneration |
Primary outcome
Capability of tear biomarkers to discriminate individuals with neurodegeneration from those without neurodegeneration and assess the change in biomarker levels over time.
Time frame: 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.
3 secondary outcomes
The difference in tear biomarker level between patients and controls, and between patient groups and how these differences change over time.
Time frame: Sampling done at t= 0, 1 and 2 years.
Correlation of biomarker levels in tears, blood and cerebral spinal fluid (CSF).
Time frame: Baseline measurements (t=0) will be used to determine correlation.
Correlation between tear biomarkers and other ocular imaging biomarkers, as well as assessing the change of this correlation over time.
Time frame: Imaging done at t= 0, 1 and 2 years.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Derived from this study: PubMed 37543602van de Sande N, Ramakers IHGB, Visser PJ, Verhey FRJ, Verbraak FD, Bouwman FH, Berendschot TTJM, Nuijts RMMA, Webers CAB, Gijs M. Tear biomarkers for Alzheimer's disease screening and diagnosis (the TearAD study): design and rationale of an observational longitudinal multicenter study. BMC Neurol. 2023 Aug 5;23(1):293. doi: 10.1186/s12883-023-03335-y.
- Individual participant dataSharing planned: Undecided
Related trials for Alzheimer Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marlies Gijs, PhD principal investigator
Maastricht University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by Maastricht University Medical Center at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Capability of tear biomarkers to discriminate individuals with neurodegeneration from those without neurodegeneration and assess the change in biomarker levels over time. (time frame: Sampling done at t= 0, 1 and 2 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05655793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.