Clinical trial NCT06661564: Identification of Diagnosis Biomarkers in the Tears of Alzheimer's Disease Patients: the COG-EYE Pilot Study
Official title: Identification De Biomarqueurs Diagnostiques Dans Les Larmes De Patients Atteints De Maladie D'Alzheimer : L'étude Pilote COG-EYE
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: biomarkers
tears
metabolomic
lipidomic
Alzheimer disease
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2024-10-28
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Participant affiliated in French Social Security scheme
* Informed and written consent from the participant

Exclusion Criteria:

* 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

Primary outcomes:
measure: Concentration of total Tau proteins in basal tears of patients with AD vs healthy volunteers
timeFrame: At inclusion
measure: Concentration of phosphorylated Tau proteins in basal tears of patients with AD vs healthy volunteers
timeFrame: At inclusion
measure: Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD vs healthy volunteers
timeFrame: At inclusion
measure: Concentration of Amyloid β 1-42 in basal tears of patients with AD vs healthy volunteers
timeFrame: At inclusion
measure: Lipids in basal tears of patients with AD vs healthy volunteers
timeFrame: At inclusion
measure: Metabolites in basal tears of patients with AD vs healthy volunteers
timeFrame: At inclusion
Secondary outcomes:
measure: Concentration of total Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
timeFrame: At inclusion
measure: Concentration of phosphylated Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
timeFrame: A inclusion
measure: Concentration of Amyloid β 1-40 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
timeFrame: A inclusion
measure: Concentration of Amyloid β 1-42 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
timeFrame: A inclusion
measure: Lipids in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
timeFrame: At inclusion
measure: Metabolites in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI
timeFrame: At inclusion
measure: Concentration of total Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
timeFrame: At inclusion
measure: Concentration of phosphorylated Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
timeFrame: At inclusion
measure: Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
timeFrame: At inclusion
measure: Concentration of Amyloid β 1-42 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI
timeFrame: At inclusion
measure: Lipids in basal tears of patients with AD-dementia vs patients with AD-MCI
timeFrame: At inclusion
measure: Metabolites in basal tears of patients with AD-dementia vs patients with AD-MCI
timeFrame: At inclusion
Other outcomes:
Locations:
city: Tours
country: France
facility: CHRU de Tours
Study officials:
affiliation: CHRU de Tours
name: Victoire LEROY, MD
role: STUDY_DIRECTOR
References: