Alzheimer DiseaseCOG-EYENCT06661564
Identification of Diagnosis Biomarkers in the Tears of Alzheimer's Disease Patients: The COG-EYE Pilot Study
A study testing 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) and Collection of a blood sample (5 mL) for blood biomarkers analysis in people with Alzheimer Disease, run by University Hospital, Tours at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- 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) and Collection of a blood sample (5 mL) for blood biomarkers analysis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2025to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Participant affiliated in French Social Security scheme
- Informed and written consent from the participant
Who cannot join
- Pregnant or breastfeeding woman
- Participant under judicial protection measures
- Participant under guardianship or curatorship
- Contraindications to participation in the research:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Raoul Kanav KHANNA, MD, PhD contact
France1 site, 1 recruiting
- Recruiting
CHRU de Tours
Tours, France, 37044
Victoire LEROY, +332 47 47 76 93, victoire.leroy@univ-tours.fr
Coralie TAILLEBUIS, +332 47 47 39 09, cpcq@chu-tours.fr
About this study
Official title: Identification de Biomarqueurs Diagnostiques Dans Les Larmes de Patients Atteints de Maladie d'Alzheimer : l'étude Pilote COG-EYE
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.
- Conditions
- Alzheimer Disease
- Being tested
- 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), Collection of a blood sample (5 mL) for blood biomarkers analysis
- Keywords
- biomarkers, tears, metabolomic, lipidomic, Alzheimer disease
- Medical subject headings
- Alzheimer Disease, Lacerations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Collection of a blood sample (5 mL) for blood biomarkers analysisOther
Collection of a blood sample (5 mL) for blood biomarkers analysis.
| Study group | Role | What they receive |
|---|---|---|
| Patients with AD dementia | Active comparator | Patient ≥ 18 years old with AD at a major stage according to the 2018 NIA-AA criteria (dementia) Receives: Other: 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) |
| 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) Receives: Other: 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 blood sample (5 mL) for blood biomarkers analysis |
| 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 Receives: Other: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At inclusion
Secondary outcomes (12)
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
Measured: At inclusion
Concentration of phosphylated 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start9 Jul 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Victoire LEROY, MD, Study director, CHRU de Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661564
- Sponsor's protocol ID
- DR240140
- Acronym
- COG-EYE
- Status last verified
- Nov 2026
- First submitted
- 16 Oct 2024
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may obtain access to all deidentified data in COG-EYE on a substantial request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification de Biomarqueurs Diagnostiques Dans Les Larmes de Patients Atteints de Maladie d'Alzheimer : l'étude Pilote COG-EYE
- ClinicalTrials.gov ID
- NCT06661564
- Acronym / sponsor ID
- COG-EYE / DR240140
- Conditions
- Alzheimer Disease
- Keywords
- biomarkers, tears, metabolomic, lipidomic, Alzheimer disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 9 Jul 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with AD dementia | Active comparator | Other: 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)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 | Other: 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 blood sample (5 mL) for blood biomarkers analysisPatient ≥ 18 years old with AD at a minor stage according to the 2018 NIA-AA criteria (Mild Cognitive Impairment) |
| Healthy controls | Sham comparator | Other: 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)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥18 years
- Participant affiliated in French Social Security scheme
- Informed and written consent from the participant
Key exclusion criteria (6 listed)
- Pregnant or breastfeeding woman
- Participant under judicial protection measures
- Participant under guardianship or curatorship
- Contraindications to participation in the research:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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)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 | Other | Healthy controls, Patients with AD Mild Cognitive Impaiment (MCI), Patients with AD dementia |
| Collection of a blood sample (5 mL) for blood biomarkers analysisCollection of a blood sample (5 mL) for blood biomarkers analysis. | Other | Patients with AD Mild Cognitive Impaiment (MCI) |
Primary outcome
Concentration of total Tau proteins in basal tears of patients with AD vs healthy volunteers
Time frame: 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
Concentration of phosphorylated Tau proteins in basal tears of patients with AD vs healthy volunteers
Time frame: 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
Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD vs healthy volunteers
Time frame: 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
Concentration of Amyloid β 1-42 in basal tears of patients with AD vs healthy volunteers
Time frame: 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
Lipids in basal tears of patients with AD vs healthy volunteers
Time frame: At inclusion
Collection of tears (5μL) using a glass micropipette without local anaesthetic. Lipids in tears of patients with AD vs healthy volunteers
Metabolites in basal tears of patients with AD vs healthy volunteers
Time frame: At inclusion
Collection of tears (5μL) using a glass micropipette without local anaesthetic. Metabolites in tears of patients with AD vs healthy volunteers
12 secondary outcomes
Concentration of total Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Time frame: At inclusion
Concentration of phosphylated Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Time frame: A inclusion
Concentration of Amyloid β 1-40 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Time frame: A inclusion
Concentration of Amyloid β 1-42 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Time frame: A inclusion
Lipids in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Time frame: At inclusion
Metabolites in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
Time frame: At inclusion
Concentration of total Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
Time frame: At inclusion
Concentration of phosphorylated Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
Time frame: At inclusion
Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
Time frame: At inclusion
Concentration of Amyloid β 1-42 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
Time frame: At inclusion
Lipids in basal tears of patients with AD-dementia vs patients with AD-MCI
Time frame: At inclusion
Metabolites in basal tears of patients with AD-dementia vs patients with AD-MCI
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Qualified researchers may obtain access to all deidentified data in COG-EYE on a substantial request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raoul Kanav KHANNA, MD, PhD contact
Victoire LEROY, MD study director
CHRU de Tours
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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) and Collection of a blood sample (5 mL) for blood biomarkers analysis in people with Alzheimer Disease, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoire LEROY, MD (0247477693, victoire.leroy@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of total Tau proteins in basal tears of patients with AD vs healthy volunteers (time frame: At inclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.