Collecting small nasal tissue samples to examine smell-sensing cells

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective study collects olfactory lining tissue from the nasal cavity of healthy adults and people with conditions that can affect smell, including Alzheimer's, post-viral smell loss, inflammatory sinonasal disease, and aging. Participants will undergo standard psychophysical smell testing and some may briefly sniff specific odors to stimulate olfactory cells before tissue collection. Biopsies are obtained in the otolaryngology clinic or during unrelated endoscopic nasal surgery using a punch technique or a cytology brush. Samples are processed in the investigator's lab for histology, primary cell culture, flow cytometry, and transcriptomic assays including RNA-seq/act-seq to characterize cell populations and activity.

Why it matters

Who can join: the full rules

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

Where it's running

• Duke University Health Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Bradley Goldstein, MD, PhD — Duke University
• Study coordinator: Maria J Manson, MBA
• Email: maria.manson@duke.edu
• Phone: (919) 684-0525

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.