Olfactory Biopsies

ConditionsAlzheimer Disease Smell Loss Smell Dysfunction

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorDuke University

About this trial

This research study aims to investigate the function of the olfactory lining in the nasal cavity and its potential alterations in both healthy and diseased conditions. The olfactory lining is involved in the sense of smell.

The purpose of this study is to collect tissue from the nasal cavity.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Between the ages of 18 and 80

Pre-clinical AD (this cohort consists of subjects who have normal cognitive testing and function, but have positive AD biomarkers);

Symptomatic AD (a confirmed diagnosis of Alzheimer's or dementia who are capable of understanding and signing the consent document)

Disqualifiers

Advanced Alzheimer's/dementia

Self-reported or known allergy to Afrin or Tetracain HCL (or related class of drugs)

Active Rhinosinusitis symptoms

Other known sinonasal disease history that would preclude biopsy (i.e prior sinus or skull base surgery directly impacting this anatomic region, sinonasal neoplasm in this anatomic region, olfactory cleft polyps)

Trial design

Design model

Parallel

Treatments tested in this trial

olfactory testing
Diagnostic test
Patients will undergo smell testing, using the Smell Identification Test (Sensonics), a validated widely-used 40-item "scratch-and-sniff" style psychophysical test to determine olfactory function.
Odor stimulation
Other intervention
subset of patients will be asked to sniff a specific odor for about an hour, using commercially available "odor pens" (Sniffin' Sticks or Sensonics). These odor pens are widely used for olfactory training therapy, a treatment designed to help people with some forms of smell loss; they are also used in psychophysical olfactory testing.
Olfactory biopsy
Procedure/Surgery
Biopsy involves a simple cytology brush technique of the lining of the nose in a region called the olfactory cleft, using a nasal endoscope, and can be done in clinic or in the operating room at the time of a nasal surgery. Topical oxymetazoline and tetracaine spray is applied to the nasal cavity, a rigid nasal endoscopy (0-degree 4 mm endoscope, Karl Storz) is performed to visualize the olfactory cleft, and a small nasal cytology brush biopsy (Hobbs Medical)is performed by swabbing and rotating brush gently in the olfactory cleft. Cytology sample is placed into a buffer (Hibernate-E, Thermo Fisher)on ice for transport to the research lab.

Treatment groups

125 Participants

are divided into 2 treatment groups

Group A: Alzheimer's studyOther 3 interventions

Group B: Act-seq study or Non-AD controlsOther 3 interventions

Trial outcomes

Primary outcomes

Transcription state changes in olfactory cells

Using single cell RNA-sequencing, olfactory epithelial cell populations will be analyzed for changes in coherent gene expression programs from subjects in different environmental conditions.

Time frame

study is planned for completion over 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Source ClinicalTrials.gov

Apply now