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NCT05791552: NL02

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

Status unknown NA Last updated 30 March 2023
What this trial tests

NA trial testing Collection of nasal secretion in Nasal Secretion in 500 participants. Status unknown.

Timeline
15 February 2022
Primary endpoint
1 June 2023
1 September 2023

Quick facts

Lead sponsorNoselab GmbH
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposediagnostic
Enrollment500
Start date15 February 2022
Primary completion1 June 2023
Estimated completion1 September 2023
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

Noselab GmbH

Who can join

18 and older, any sex, with Nasal Secretion or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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