The TearAD Study: Tear Biomarkers for Alzheimer's Disease (AD) Screening and Diagnosis
NCT ID: NCT05655793
Last Updated: 2024-03-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
200 participants
OBSERVATIONAL
2022-06-09
2025-07-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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With Neurodegeneration
Includes patients with mild cognitive impairment and dementia
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.
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
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
50 Years
ALL
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Marlies Gijs, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht University Medical Center
Locations
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Academic Hospital Maastricht
Maastricht, Limburg, Netherlands
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Frank Verbraak, MD, PhD
Role: primary
References
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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.
Other Identifiers
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20-033
Identifier Type: -
Identifier Source: org_study_id
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