The TearAD Study: Tear Biomarkers for Alzheimer's Disease (AD) Screening and Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Capability of tear biomarkers to discriminate individuals with neurodegeneration from those without neurodegeneration and assess the change in biomarker levels over time.
研究概览
简要总结
The goal of this observational longitudinal study is to investigates whether tear fluid is a non-invasive source of biomarkers for Alzheimer's disease. The main aim of the study is to evaluate diagnostic accuracy measures (sensitivity and specificity) of tear and retinal biomarkers to discriminate individuals with and without neurodegeneration.
Tear fluid from participants will be collected non-invasively with Schirmer's strips, which is a small paper strip placed in the lower eye lid for a maximum of 5 minutes. Additionally, standard, ultra-wide field and cross-sectional retinal images will be obtained.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Capability of tear biomarkers to discriminate individuals with neurodegeneration from those without neurodegeneration and assess the change in biomarker levels over time.
时间窗: Sampling done at t= 0, 1 and 2 years.
Levels of tear biomarkers will be determined from the Schirmer's strips. The biomarker levels will be analysed to see whether they can be discriminate between people with and without neurodegeneration.
次要结局
- Correlation of biomarker levels in tears, blood and cerebral spinal fluid (CSF).(Baseline measurements (t=0) will be used to determine correlation.)
- The difference in tear biomarker level between patients and controls, and between patient groups and how these differences change over time.(Sampling done at t= 0, 1 and 2 years.)
- Correlation between tear biomarkers and other ocular imaging biomarkers, as well as assessing the change of this correlation over time.(Imaging done at t= 0, 1 and 2 years.)