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

March 12, 2024 updated by: Maastricht University Medical Center

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • Recruiting
        • Amsterdam University Medical Center
        • Contact:
          • Frank Verbraak, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
With Neurodegeneration
Includes patients with mild cognitive impairment and dementia
Diagnostic test: 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: Retinal 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.
Without Neurodegeneration
Includes healthy controls and patients with subjective cognitive decline
Diagnostic test: 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: Retinal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Sampling done at t= 0, 1 and 2 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Additional analysis to see whether tear biomarkers can also discriminate patients from controls and differences inbetween patient groups.
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.
This analysis will be done to determine the correlation between biomarkers of different body fluids.
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.
The correlation between tear biomarkers and ocular imaging biomarkers (e.g. thickness of the retinal nerve fiber layer, retinal vasculature tortuosity) will be analysed.
Imaging done at t= 0, 1 and 2 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Marlies Gijs, PhD, Maastricht University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2022

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

December 16, 2022

First Posted (Actual)

December 19, 2022

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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