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The diagnosis of Alzheimer's disease (AD) relies on the detection of protein biomarkers, particularly in cerebrospinal fluid (e.g., Aβ and phosphorylated Tau) or through brain imaging. The invasive nature of lumbar puncture and the numerous contraindications have driven the search for early and reliable diagnostic biomarkers for AD.
Human tears are an accessible biological fluid that has proven relevant in the biomarker search strategy for both ophthalmological and systemic diseases, especially neurodegenerative conditions. Advances in methods for low-volume analysis have facilitated the identification of tear biomarkers. Total tau has been reported as elevated in the tears of patients with AD compared to controls (n=65). Additionally, metabo-lipidomic analyses offer several advantages (accessibility, non-invasiveness, reproducibility) and also appear promising as a diagnostic tool for systemic and neurodegenerative diseases, such as amyotrophic lateral sclerosis. This supports the relevance of comparing both AD proteins biomarkers and metabo-lipidomic signatures in the tears of patients with AD (Mild Cognitive Impairement (MCI) and dementia) with healthy controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with AD dementia | Active Comparator | Patient ≥ 18 years old with AD at a major stage according to the 2018 NIA-AA criteria (dementia) |
|
| Patients with AD Mild Cognitive Impaiment (MCI) | Active Comparator | Patient ≥ 18 years old with AD at a minor stage according to the 2018 NIA-AA criteria (Mild Cognitive Impairment) |
|
| Healthy controls | Sham Comparator | Participants ≥ 18 years old with no known central neurological pathology, no cognitive decline, and matched by age (± 2 years) and sex with a patient from AD-MCI group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Basal tear collection for the analysis of metabo-lipidomic profiles and concentrations of protein biomarkers (Tau, phosphorylated Tau, Aβ 1-40, and Aβ 1-42) | Other | Collection of a tear volume of (i) 2 x 5µL using glass microcapillary tubes and (ii) 12µL using Schirmer strips after the instillation of anesthetic eye drops for metabo-lipidomic analysis and multiplexing of protein markers |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of total Tau proteins in basal tears of patients with AD vs healthy volunteers | 12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest | At inclusion |
| Concentration of phosphorylated Tau proteins in basal tears of patients with AD vs healthy volunteers | 12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest | At inclusion |
| Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD vs healthy volunteers | 12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest | At inclusion |
| Concentration of Amyloid β 1-42 in basal tears of patients with AD vs healthy volunteers | 12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest | At inclusion |
| Lipids in basal tears of patients with AD vs healthy volunteers | Collection of tears (5μL) using a glass micropipette without local anaesthetic. Lipids in tears of patients with AD vs healthy volunteers | At inclusion |
| Metabolites in basal tears of patients with AD vs healthy volunteers | Collection of tears (5μL) using a glass micropipette without local anaesthetic. Metabolites in tears of patients with AD vs healthy volunteers |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of total Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI | 12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest | At inclusion |
| Concentration of phosphylated Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI |
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Inclusion Criteria:
Exclusion Criteria:
Other neurodegenerative disease Any eye drops or treatment that may interfere with tear production Occasional or permanent contact lens use within the last 3 months Eye surgery ≤3 months Any ocular pathology other than refractive errors, oculomotor disorders, amblyopia Any general pathology other than AD with ocular implications
-Inability to perform tear collection
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoire LEROY, MD | Contact | 0247477693 | victoire.leroy@univ-tours.fr | |
| Raoul Kanav KHANNA, MD, PhD | Contact | raoul.khanna@univ-tours.fr |
| Name | Affiliation | Role |
|---|---|---|
| Victoire LEROY, MD | CHRU de Tours | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Tours | Recruiting | Tours | France | 37044 | France |
Qualified researchers may obtain access to all deidentified data in COG-EYE on a substantial request.
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|
| Collection of a blood sample (5 mL) for blood biomarkers analysis | Other | Collection of a blood sample (5 mL) for blood biomarkers analysis. |
|
| At inclusion |
12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest |
| A inclusion |
| Concentration of Amyloid β 1-40 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI | 12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest | A inclusion |
| Concentration of Amyloid β 1-42 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI | 12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest | A inclusion |
| Lipids in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI | Collection of tears (5μL) using a glass micropipette without local anaesthetic. Identification of lipids in basal tears using liquid chromatography-mass spectrometry. | At inclusion |
| Metabolites in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI | Collection of tears (5μL) using a glass micropipette without local anaesthetic. Identification of metabolites in basal tears using liquid chromatography-mass spectrometry. | At inclusion |
| Concentration of total Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI | 12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest | At inclusion |
| Concentration of phosphorylated Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI | 12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest | At inclusion |
| Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI | 12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest | At inclusion |
| Concentration of Amyloid β 1-42 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI | 12μL of tears will be collected using Schirmer strips after instillation of an anaesthetic eye drop. A multiplex analysis for the detection of protein of interest | At inclusion |
| Lipids in basal tears of patients with AD-dementia vs patients with AD-MCI | Collection of tears (5μL) using a glass micropipette without local anaesthetic. Identification of lipids in basal tears using liquid chromatography-mass spectrometry. | At inclusion |
| Metabolites in basal tears of patients with AD-dementia vs patients with AD-MCI | Collection of tears (5μL) using a glass micropipette without local anaesthetic. Identification of metabolites in basal tears using liquid chromatography-mass spectrometry. | At inclusion |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D016875 | tau Proteins |
| ID | Term |
|---|---|
| D008869 | Microtubule-Associated Proteins |
| D008868 | Microtubule Proteins |
| D003598 | Cytoskeletal Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
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