Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion
NL02
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2022
CompletedFirst Submitted
Initial submission to the registry
March 14, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedMarch 30, 2023
March 1, 2023
1.3 years
March 14, 2023
March 28, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Detection of brain specific biomarkers in nasal secretion
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
Assess ranges of biomarkers for AD in nasal secretion of cognitively impaired patients with and without AD and healthy controls
1-2 years
Study Arms (2)
Group A
OTHERPatient WITH cognitive impairment and no nasal pathologies. CSF analysis is planned or results are already available
Group B
OTHERPatient WITHOUT cognitive impairment and without nasal pathologies
Interventions
Standardized collection of nasal secretion in the vicinity of the olfactory cleft
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Presence of an obstructing nasal cavity disease
- Patient suffers from an acute upper respiratory tract infection (putrid rhinorrhea)
- Inability to give consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Noselab GmbHlead
Study Sites (1)
Noselab GmbH
München, Bavaria, 80538, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2023
First Posted
March 30, 2023
Study Start
February 15, 2022
Primary Completion
June 1, 2023
Study Completion
September 1, 2023
Last Updated
March 30, 2023
Record last verified: 2023-03