Olfactory Biopsies

Launched by DUKE UNIVERSITY · Jun 5, 2025

Keywords

ClinConnect Summary

This clinical trial, called "Olfactory Biopsies," is looking into how the sense of smell works and whether it changes in people with Alzheimer’s disease and other conditions. The researchers want to collect small samples of tissue from the nasal lining, which is responsible for our sense of smell, to better understand these changes. The study is currently recruiting participants aged 18 to 80, including those diagnosed with Alzheimer’s or those showing early signs of the disease, as well as individuals who have smell disorders for other reasons.

Participants in the study can expect to undergo a nasal endoscopy, a procedure where a thin tube with a camera is inserted into the nose to help collect tissue samples. To be eligible for the Alzheimer’s group, individuals must either have early signs of Alzheimer’s or a confirmed diagnosis of the disease but still be able to understand and consent to participate. For the other group, individuals must be 18 or older and have nasal issues that require surgery. It’s important to note that some people may not qualify if they have certain allergies or conditions affecting the nasal area. This study aims to improve our understanding of how smell is affected in Alzheimer’s, which could lead to better diagnosis and treatments in the future.

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Eligibility criteria

• • 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