Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion (NL02)

Noselab

Status: Enrolling

Conditions: Alzheimer Disease; Nasal Secretion; Brain Nose Interface

Treatments: Diagnostic Test: Collection of nasal secretion

Study type: Interventional

Funder types: Industry

Identifiers

NCT05791552

MUC-00

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Group A

Other group

Description:

Patient WITH cognitive impairment and no nasal pathologies. CSF analysis is planned or results are already available

Treatment:

Diagnostic Test: Collection of nasal secretion

Group B

Other group

Description:

Patient WITHOUT cognitive impairment and without nasal pathologies

Treatment:

Diagnostic Test: Collection of nasal secretion