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

Sponsor

Noselab GmbH (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05791552

Collaborator

(none)

500

Enrollment

Location

Arms

18.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasal Secretion Alzheimer Disease Brain Nose Interface	Diagnostic Test: Collection of nasal secretion	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

500 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 15, 2022

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Group A

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

Diagnostic Test: Collection of nasal secretion

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

Other: Group B

Patient WITHOUT cognitive impairment and without nasal pathologies

Diagnostic Test: Collection of nasal secretion

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Noselab GmbH	München	Bayern	Germany	80538

Sponsors and Collaborators

Noselab GmbH

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Noselab GmbH

ClinicalTrials.gov Identifier:

NCT05791552

Other Study ID Numbers:

MUC-00

First Posted:

Mar 30, 2023

Last Update Posted:

Mar 30, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Mar 30, 2023