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

Alzheimer Disease Clinical Trial

— NL02  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05791552
• Other study ID #: MUC-00
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: March 2023
• Source: Noselab GmbH
• Contact: Marion San Nicoló, MD
• Phone: +49892302680
• Email: marion.sannicolo[@]noselab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: September 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease

Intervention

Diagnostic Test:
• Collection of nasal secretion
Standardized collection of nasal secretion in the vicinity of the olfactory cleft

Locations

Country	Name	City	State
Germany	Noselab GmbH	München	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Noselab GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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