Identification of Diagnosis Biomarkers in the Tears of Alzheimer's Disease Patients: The COG-EYE Pilot Study

Официальное название

Identification de Biomarqueurs Diagnostiques Dans Les Larmes de Patients Atteints de Maladie d'Alzheimer : l'étude Pilote COG-EYE

Обзор

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.

Вмешательства

• Другое 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
• Другое Collection of a blood sample (5 mL) for blood biomarkers analysis
  Collection of a blood sample (5 mL) for blood biomarkers analysis.

Первичные конечные точки

• Concentration of total Tau proteins in basal tears of patients with AD vs healthy volunteers [Срок оценки: At inclusion]
• Concentration of phosphorylated Tau proteins in basal tears of patients with AD vs healthy volunteers [Срок оценки: At inclusion]
• Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD vs healthy volunteers [Срок оценки: At inclusion]
• Concentration of Amyloid β 1-42 in basal tears of patients with AD vs healthy volunteers [Срок оценки: At inclusion]
• Lipids in basal tears of patients with AD vs healthy volunteers [Срок оценки: At inclusion]
• Metabolites in basal tears of patients with AD vs healthy volunteers [Срок оценки: At inclusion]

Вторичные конечные точки (12)

• Concentration of total Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI [Срок оценки: At inclusion]
• Concentration of phosphylated Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI [Срок оценки: A inclusion]
• Concentration of Amyloid β 1-40 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI [Срок оценки: A inclusion]
• Concentration of Amyloid β 1-42 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI [Срок оценки: A inclusion]
• Lipids in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI [Срок оценки: At inclusion]
• Metabolites in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI [Срок оценки: At inclusion]
• Concentration of total Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI [Срок оценки: At inclusion]
• Concentration of phosphorylated Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI [Срок оценки: At inclusion]
• Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI [Срок оценки: At inclusion]
• Concentration of Amyloid β 1-42 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI [Срок оценки: At inclusion]
• Lipids in basal tears of patients with AD-dementia vs patients with AD-MCI [Срок оценки: At inclusion]
• Metabolites in basal tears of patients with AD-dementia vs patients with AD-MCI [Срок оценки: At inclusion]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Франция · 1 центр

• CHRU de Tours — Tours

Идентификаторы

NCT: NCT06661564 · DR240140

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗