RecruitingNot ApplicableNCT07021040

Olfactory Biopsies

Analysis of Human Olfactory Biopsies


Sponsor

Duke University

Enrollment

125 participants

Start Date

Jan 6, 2025

Study Type

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining tissue samples taken from the lining inside the nose (olfactory biopsies) in people with Alzheimer's disease or Parkinson's disease, to look for early signs of these conditions at the cellular level. **You may be eligible if...** - You are between 18 and 80 years old - You have early or pre-clinical Alzheimer's disease (normal thinking but positive biomarkers), OR a confirmed Alzheimer's/dementia diagnosis and can consent - OR you have Parkinson's disease (separate cohort) **You may NOT be eligible if...** - You have advanced Alzheimer's disease or dementia - You are allergic to nasal spray anesthetics (Afrin or Tetracaine) - You have active sinus problems, sinus surgery history, or nasal polyps in the relevant area - You are unable or unwilling to complete the nasal procedure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTolfactory 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.

OTHEROdor 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.

PROCEDUREOlfactory 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

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NCT07021040


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