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

NCT05655793 | Recruiting DMC

• 1 other identifier: 20-033
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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 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

Keywords

Tear Fluid; Retinal imaging; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Sampling done at t= 0, 1 and 2 years.

• Correlation of biomarker levels in tears, blood and cerebral spinal fluid (CSF).

  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.

  Imaging done at t= 0, 1 and 2 years.

Study Arms (2)

With Neurodegeneration

Includes patients with mild cognitive impairment and dementia

Diagnostic Test: Tear Fluid collection (Schirmer's strip); Diagnostic Test: Retinal imaging

Without Neurodegeneration

Includes healthy controls and patients with subjective cognitive decline

Diagnostic Test: Tear Fluid collection (Schirmer's strip); Diagnostic Test: Retinal imaging

Interventions

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.

With Neurodegeneration; Without Neurodegeneration

Retinal imaging DIAGNOSTIC_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.

With Neurodegeneration; Without Neurodegeneration

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 for follow-up (up to 24 months)
• Written informed consent obtained and documented
• Capable of giving informed consent themselves (MMSE score \> 17/30)

You may not qualify if:

• 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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (2)

Academic Hospital Maastricht

Maastricht, Limburg, 6229 HX, Netherlands

RECRUITING

Amsterdam University Medical Center

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 37543602 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

The type of biospecimen that is retained is tear fluid collected with Schirmer's strips, CSF and blood.

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Marlies Gijs, PhD

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlies Gijs, PhD

CONTACT

+31 (0)43 3872241; marlies.gijs@mumc.nl

Nienke van de Sande, MSc

CONTACT

+31 (0)43 3875345; nienke.van.de.sande@mumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2022
• First Posted: December 19, 2022
• Study Start: June 9, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

NL (2)