Olfactory Biopsies
Analysis of Human Olfactory Biopsies
Duke University
125 participants
Jan 6, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria7
- Group 1: Alzheimer's study
- 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)
- Age 18 years or older
- Patients being seen for rhinology or olfactory disorders
- Patients having unrelated endoscopic nasal surgery
Exclusion Criteria13
- 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
- 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
Interventions
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.
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07021040