Olfactory Biopsies

Not Applicable

Recruiting

• Conditions: Alzheimer Disease; Smell Loss; Smell Dysfunction

• Registration Number: NCT07021040
• Lead Sponsor: Duke University

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.

Study Timeline

• Study Start: 2025-01-06
• Status Verified: 2025-06
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Submitted: 2025-06-18
• Last Update Posted: 2025-06-24
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Transcription state changes in olfactory cells	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.

Trial Locations

Locations (1)

Duke University Health Center; 🇺🇸 Durham, North Carolina, United States