Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion

Study Overview
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Brief Summary
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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.

Official Title
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Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion

Conditions
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Nasal Secretion, Alzheimer Disease, Brain Nose Interface

Intervention / Treatment
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* Diagnostic Test: Collection of nasal secretion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group A<br>Patient WITH cognitive impairment and no nasal pathologies. CSF analysis is planned or results are already available | Diagnostic Test: Collection of nasal secretion<br>* Standardized collection of nasal secretion in the vicinity of the olfactory cleft<br>|
| Other: Group B<br>Patient WITHOUT cognitive impairment and without nasal pathologies | Diagnostic Test: Collection of nasal secretion<br>* Standardized collection of nasal secretion in the vicinity of the olfactory cleft<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection 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. | 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 | 1-2 years |