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

March 28, 2023 updated by: Noselab GmbH
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Bayern
      • München, Bayern, Germany, 80538

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of brain specific biomarkers in nasal secretion
Time Frame: 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.
1-2 years
Distinction of pathologic and physiologic biomarker patterns in nasal secretion
Time Frame: 1-2 years
Assess ranges of biomarkers for AD in nasal secretion of cognitively impaired patients with and without AD and healthy controls
1-2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Noselab GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MUC-00

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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