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RECRUITINGINTERVENTIONAL

Olfactory Biopsies

Analysis of Human Olfactory Biopsies

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Group 1: Alzheimer's study Who May Qualify: - 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) Who Should NOT Join This Trial: - 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 Who May Qualify: - Age 18 years or older - Patients being seen for rhinology or olfactory disorders - Patients having unrelated endoscopic nasal surgery Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DIAGNOSTIC_TEST

olfactory testing

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.

OTHER

Odor stimulation

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.

PROCEDURE

Olfactory biopsy

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)

Duke University Health Center
Durham, North Carolina, United States