Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Distinction of pathologic and physiologic biomarker patterns in nasal secretion
研究概览
简要总结
This study is a first in man study investigating the feasibility of the collection, storage, processing and analysis of 4 key biomarkers for the diagnosis of Alzheimer's disease [AD] in nasal secretion. Nasal secretion [NS] constitutes a minimally invasive access to cerebrospinal fluid [CSF]. Therefore, it could be highly suitable for detection and monitoring of the AD relevant biomarkers pTau181, total Tau, Amyloid-ß1-40 and Amyloid-ß1-42. This study evaluates correlations of biomarker patterns in NS and CSF. Furthermore, the correlations of the 4 AD specific biomarkers in nasal secretion and CSF is investigated. For this study, patients with cognitive impairment (AD and NonAD group) and healthy controls were included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Group A Patient WITH cognitive impairment and no nasal pathologies. CSF analysis is planned or results are already available
- •Group B Patient WITHOUT cognitive disorder and without pathologies in the nasal area
排除标准
- •Presence of an obstructing nasal cavity disease
- •Patient suffers from an acute upper respiratory tract infection (putrid rhinorrhea)
- •Inability to give consent
结局指标
主要结局
Distinction of pathologic and physiologic biomarker patterns in nasal secretion
时间窗: 1-2 years
Assess ranges of biomarkers for AD in nasal secretion of cognitively impaired patients with and without AD and healthy controls
Detection of brain specific biomarkers in nasal secretion
时间窗: 1-2 years
The aim of the study was to investigate the overall applicability of a new, minimally invasive, and proprietary procedure developed by the company Noselab GmbH for exclusion or detection of Alzheimer's disease (AD) and/or neurodegeneration (ND) in patients with (subjective) cognitive impairment.
次要结局
未报告次要终点