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Life sciences · Interventional Study
ClinicalTrials.gov · November 5, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06661564). This is a study registration, not published results. Lead sponsor: University Hospital, Tours. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 90 participants (ESTIMATED). Conditions: Alzheimer Disease. Interventions: 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. Primary outcome measures: Concentration of total Tau proteins in basal tears of patients with AD vs healthy volunteers , At inclusion; Concentration of phosphorylated Tau proteins in basal tears of patients with AD vs healthy volunteers , At inclusion; Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD vs healthy volunteers , At inclusion; Concentration of Amyloid β 1-42 in basal tears of patients with AD vs healthy volunteers , At inclusion; Lipids in basal tears of patients with AD vs healthy volunteers , At inclusion; Metabolites in basal tears of patients with AD vs healthy volunteers , At inclusion. 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.