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

Not Applicable

Recruiting

• Conditions: Nasal Secretion; Brain Nose Interface; Alzheimer Disease
• Interventions: Diagnostic Test: Collection of nasal secretion

• Registration Number: NCT05791552
• Lead Sponsor: Noselab GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-15
• Status Verified: 2023-03
• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Study First Posted: 2023-03-30
• Last Update Posted: 2023-03-30
• Primary Completion: 2023-06-01
• Study Completion: 2023-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	Collection of nasal secretion	Patient WITHOUT cognitive impairment and without nasal pathologies
Group A	Collection of nasal secretion	Patient WITH cognitive impairment and no nasal pathologies. CSF analysis is planned or results are already available

Primary Outcome Measures

Name	Time	Method
Distinction of pathologic and physiologic biomarker patterns in nasal secretion	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	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.

Trial Locations

Locations (1)

Noselab GmbH; 🇩🇪 München, Bayern, Germany