Olfactory Biopsies
Purpose
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.
Conditions
- Alzheimer Disease
- Smell Loss
- Smell Dysfunction
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Alzheimer's study | Olfactory function will be assessed using the Smell Identification Test (SIT, Sensonics, Inc) or Sniffin' Sticks Test. Using topical intranasal decongestion/anesthetic (oxymetazoline/lidocaine), a cytology brush biopsy will be obtained from the olfactory cleft region of the nose in clinic exam room using a nasal endoscope. | |
| Act-seq study or Non-AD controls | Olfactory function will be measured using established psychophysical testing via the Smell Identification Test or Sniffin' Sticks. Researchers will obtain biopsies from (1) normosmic subjects with or without odor stimulation, and (2) hyposmic subjects with history of upper respiratory infection (URI) as likely cause of the smell loss (such as COVID19) with or without odor stimulation. |
Recruiting Locations
Durham, North Carolina 27710
More Details
- NCT ID
- NCT07021040
- Status
- Recruiting
- Sponsor
- Duke University
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.