Nasal SecretionNL02NCT05791552
Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion
A study testing Collection of nasal secretion in people with Nasal Secretion and Alzheimer Disease, run by Noselab GmbH at 1 site in Germany.
Trial 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]. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Secretion, Alzheimer Disease, Brain Nose Interface
- What is being tested?
- Collection of nasal secretion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 15 Feb 2022to 1 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Presence of an obstructing nasal cavity disease
- Patient suffers from an acute upper respiratory tract infection (putrid rhinorrhea)
- Inability to give consent
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Noselab GmbH
München, Bavaria, 80538
Marion San Nicoló, MD, +49892302680 ext. 1, marion.sannicolo@noselab.com
Gabriele C Baur, +49892302680 ext. 1, gabriele.baur@noselab.com
About this study
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.
- Conditions
- Nasal Secretion, Alzheimer Disease, Brain Nose Interface
- Being tested
- Collection of nasal secretion
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of nasal secretionDiagnostic test
Standardized collection of nasal secretion in the vicinity of the olfactory cleft
| Study group | Role | What they receive |
|---|---|---|
| Group A | Other | Patient WITH cognitive impairment and no nasal pathologies. CSF analysis is planned or results are already available Receives: Diagnostic Test: Collection of nasal secretion |
| Group B | Other | Patient WITHOUT cognitive impairment and without nasal pathologies Receives: Diagnostic Test: Collection of nasal secretion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start15 Feb 2022
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal SecretionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Noselab GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791552
- Sponsor's protocol ID
- MUC-00
- Acronym
- NL02
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion
- ClinicalTrials.gov ID
- NCT05791552
- Acronym / sponsor ID
- NL02 / MUC-00
- Conditions
- Nasal Secretion, Alzheimer Disease, Brain Nose Interface
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Noselab GmbHIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Diagnostic Test: Collection of nasal secretionPatient WITH cognitive impairment and no nasal pathologies. CSF analysis is planned or results are already available |
| Group B | Other | Diagnostic Test: Collection of nasal secretionPatient WITHOUT cognitive impairment and without nasal pathologies |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Presence of an obstructing nasal cavity disease
- Patient suffers from an acute upper respiratory tract infection (putrid rhinorrhea)
- Inability to give consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of nasal secretionStandardized collection of nasal secretion in the vicinity of the olfactory cleft | Diagnostic test | Group A, Group B |
Primary outcome
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.
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collection of nasal secretion in people with Nasal Secretion and Alzheimer Disease, run by Noselab GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marion San Nicoló, MD (+49892302680 ext. 1, marion.sannicolo@noselab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection of brain specific biomarkers in nasal secretion (time frame: 1-2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2023.