Clinical trial NCT07021040: Olfactory Biopsies
Official title: Analysis of Human Olfactory Biopsies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Smell Loss
Smell Dysfunction
Keywords: act-seq
nasal biopsy
RNA-seq
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2025-06-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants will be recruited from Duke clinic and approached by principal investigator and collaborators

Brief summary: 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.

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

Primary outcomes:
measure: Transcription state changes in olfactory cells
timeFrame: study is planned for completion over 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Bradley Goldstein, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: