Back to resultsFeasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion (NL02)
Primary Purpose
Nasal Secretion, Alzheimer Disease, Brain Nose Interface
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Collection of nasal secretion
Sponsored by
About this trial
This is an interventional diagnostic trial for Nasal Secretion
Eligibility Criteria
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
Sites / Locations
- Noselab GmbHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group A
Group B
Arm Description
Patient WITH cognitive impairment and no nasal pathologies. CSF analysis is planned or results are already available
Patient WITHOUT cognitive impairment and without nasal pathologies
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05791552
Brief Title
Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion
Acronym
NL02
Official Title
Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noselab GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Secretion, Alzheimer Disease, Brain Nose Interface
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Other
Arm Description
Patient WITH cognitive impairment and no nasal pathologies. CSF analysis is planned or results are already available
Arm Title
Group B
Arm Type
Other
Arm Description
Patient WITHOUT cognitive impairment and without nasal pathologies
Intervention Type
Diagnostic Test
Intervention Name(s)
Collection of nasal secretion
Intervention Description
Standardized collection of nasal secretion in the vicinity of the olfactory cleft
Primary Outcome Measure Information:
Title
Detection of brain specific biomarkers in nasal secretion
Description
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.
Time Frame
1-2 years
Title
Distinction of pathologic and physiologic biomarker patterns in nasal secretion
Description
Assess ranges of biomarkers for AD in nasal secretion of cognitively impaired patients with and without AD and healthy controls
Time Frame
1-2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marion San Nicoló, MD
Phone
+49892302680
Ext
1
Email
marion.sannicolo@noselab.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mareike Haack, MD
Phone
+49892302680
Ext
1
Email
mareike.haack@noselab.com
Facility Information:
Facility Name
Noselab GmbH
City
München
State/Province
Bayern
ZIP/Postal Code
80538
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marion San Nicoló, MD
Phone
+49892302680
Ext
1
Email
marion.sannicolo@noselab.com
First Name & Middle Initial & Last Name & Degree
Gabriele C Baur
Phone
+49892302680
Ext
1
Email
gabriele.baur@noselab.com
First Name & Middle Initial & Last Name & Degree
Marion San Nicoló, MD
12. IPD Sharing Statement
Learn more about this trial
Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion
We'll reach out to this number within 24 hrs