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NCT Number: NCT07021040

Olfactory Biopsies

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.

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Key information

Conditions

Alzheimer Disease Anosmia Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Smell Dysfunction Smell Loss Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

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.

Primary outcomes

  1. Transcription state changes in olfactory cells

    Time frame: study is planned for completion over 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bradley J Goldstein, MD, PhD

CONTACT

[email protected]

(919) 684 3834

Maria J Manson, MBA

CONTACT

[email protected]

(919) 684-0525

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Analysis of Human Olfactory Biopsies

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Jun 13, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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