Identification de Biomarqueurs Diagnostiques Dans Les Larmes de Patients Atteints de Maladie d'Alzheimer : l'étude Pilote COG-EYE
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Concentration of total Tau proteins in basal tears of patients with AD vs healthy volunteers
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥18 years
- •Participant affiliated in French Social Security scheme
- •Informed and written consent from the participant
排除标准
- •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
结局指标
主要结局
Concentration of total Tau proteins in basal tears of patients with AD vs healthy volunteers
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: At inclusion
Collection of tears (5μL) using a glass micropipette without local anaesthetic. Metabolites in tears of patients with AD vs healthy volunteers
次要结局
- Concentration of total Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI(At inclusion)
- Concentration of phosphylated Tau proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI(A inclusion)
- Concentration of Amyloid β 1-40 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI(A inclusion)
- Concentration of Amyloid β 1-42 proteins in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI(A inclusion)
- Lipids in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI(At inclusion)
- Metabolites in tears vs plasma and Cerebral spinal fluid (CSF) within patients with AD-MCI(At inclusion)
- Concentration of total Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI(At inclusion)
- Concentration of phosphorylated Tau proteins in basal tears of patients with AD-dementia vs patients with AD-MCI(At inclusion)
- Concentration of Amyloid β 1-40 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI(At inclusion)
- Concentration of Amyloid β 1-42 proteins in basal tears of patients with AD-dementia vs patients with AD-MCI(At inclusion)
- Lipids in basal tears of patients with AD-dementia vs patients with AD-MCI(At inclusion)
- Metabolites in basal tears of patients with AD-dementia vs patients with AD-MCI(At inclusion)