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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
500
Standardized collection of nasal secretion in the vicinity of the olfactory cleft
Noselab GmbH
München, Bavaria, Germany
RECRUITINGDetection of brain specific biomarkers in nasal secretion
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.
Time frame: 1-2 years
Distinction of pathologic and physiologic biomarker patterns in nasal secretion
Assess ranges of biomarkers for AD in nasal secretion of cognitively impaired patients with and without AD and healthy controls
Time frame: 1-2 years
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