Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 2
- Primary Endpoint
- Distinction of pathologic and physiologic biomarker patterns in nasal secretion
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Presence of an obstructing nasal cavity disease
- •Patient suffers from an acute upper respiratory tract infection (putrid rhinorrhea)
- •Inability to give consent
Outcomes
Primary Outcomes
Distinction of pathologic and physiologic biomarker patterns in nasal secretion
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported