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Recruiting NCT07021040

Olfactory Biopsies

No phase Interventional Alzheimer Disease Smell Loss Smell Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: olfactory testing, Odor stimulation, Olfactory biopsy.
Who it may be relevant to
Registry conditions: Alzheimer Disease, Smell Loss, Smell Dysfunction. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Analysis of Human Olfactory Biopsies

Overview

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.

Detailed description

The purpose of this study is to analyze cell populations active in human olfactory tissue in health and disease. This is a prospective study. Healthy participants or participants with known disease processes that may impact olfaction, such as Alzheimer's, inflammatory conditions, aging, or post-viral smell loss, will be included. Olfaction will be measured using standard psychophysical testing. Biopsies of the olfactory lining in the nasal cavity may be obtained in the otolaryngology clinic or the operating room, if the patient is having an unrelated endoscopic nasal surgery, and may be obtained using a punch technique or a cytology brush. Before biopsies, some patients may be asked to sniff an odor substance (such as lavender, mint, citrus, or cloves) briefly, to stimulate olfactory cells. Biopsies will be processed for assays in the PI's lab, including histology, primary culture assays, flow cytometry assays, or transcriptomic profiling.

Interventions

  • Diagnostic test olfactory testing
    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.
  • Other Odor stimulation
    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.
  • Procedure Olfactory biopsy
    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

Primary outcome measures

  • Transcription state changes in olfactory cells [Time frame: study is planned for completion over 5 years]

Eligibility criteria

Group 1: Alzheimer's study

Inclusion criteria

  • 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)

Exclusion criteria

  • 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)
  • Parkinson's disease
  • Unable or willing to complete the nasal endoscopy procedure.
  • Unable to read or speak English
  • Unable to provide legally effective consent

Group 2: Act-seq study or Non-AD controls

Inclusion criteria

  • Age 18 years or older
  • Patients being seen for rhinology or olfactory disorders
  • Patients having unrelated endoscopic nasal surgery

Exclusion criteria

  • Self-reported or known allergy to Afrin or Tetracain HCL (or related class of drugs)
  • Unable or willing to complete the nasal endoscopy procedure
  • Unable to read or speak English
  • Unable to provide legally effective consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Duke University Health Center — Durham

Identifiers

NCT: NCT07021040 · Pro00116591 · 1R01DC021422-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗