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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Nasal Secretion Alzheimer Disease Brain Nose Interface

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

Patient WITH cognitive impairment and no nasal pathologies. CSF analysis is planned or results are already available

Group Type OTHER

Collection of nasal secretion

Intervention Type DIAGNOSTIC_TEST

Standardized collection of nasal secretion in the vicinity of the olfactory cleft

Group B

Patient WITHOUT cognitive impairment and without nasal pathologies

Group Type OTHER

Collection of nasal secretion

Intervention Type DIAGNOSTIC_TEST

Standardized collection of nasal secretion in the vicinity of the olfactory cleft

Interventions

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Collection of nasal secretion

Standardized collection of nasal secretion in the vicinity of the olfactory cleft

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes