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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05791552

Acronym

NL02

Enrollment

500

Registered

2023-03-30

Start date

2022-02-15

Completion date

2023-09-01

Last updated

2023-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, Brain Nose Interface, Nasal Secretion

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.

Interventions

DIAGNOSTIC_TESTCollection of nasal secretion

Standardized collection of nasal secretion in the vicinity of the olfactory cleft

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Countries

Germany

Contacts

Primary ContactMarion San Nicoló, MD

marion.sannicolo@noselab.com+49892302680

Backup ContactMareike Haack, MD

mareike.haack@noselab.com+49892302680

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026