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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With Neurodegeneration | Includes patients with mild cognitive impairment and dementia |
| |
| Without Neurodegeneration | Includes healthy controls and patients with subjective cognitive decline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. | 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. |
| 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. | 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. |
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Inclusion Criteria (healthy controls):
Inclusion criteria (patients):
Exclusion Criteria (all subjects):
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The patients will be selected from the population that visit the memory clinic and are willing to participate in scientific research.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Marlies Gijs, PhD | Maastricht University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Academic Hospital Maastricht | Recruiting | Maastricht | Limburg | 6229 HX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37543602 | Derived | 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. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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The type of biospecimen that is retained is tear fluid collected with Schirmer's strips, CSF and blood.
| 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. |
|
| 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. |
| 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. | Imaging done at t= 0, 1 and 2 years. |
| Amsterdam University Medical Center | Recruiting | Amsterdam | North Holland | 1081 HV | Netherlands |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |