Olfactory Biopsies for Alzheimer's Disease and Smell Loss

This research study aims to understand how the lining of your nose, involved in your sense of smell, changes in healthy people and those with conditions like Alzheimer's disease or smell loss. The study will collect tissue from your nasal cavity using a simple brush technique (olfactory biopsy) to analyze the cells. You might also undergo smell testing using "scratch-and-sniff" tests and, for some, sniff specific odors like lavender or mint for about an hour. The main goal is to see how the genes in these olfactory cells change over five years. You may be eligible if you are between 18 and 80 years old and have early Alzheimer's (pre-clinical AD with positive biomarkers) or diagnosed Alzheimer's disease.

Study design
This is an interventional study planning to enroll 125 participants. It is a prospective study, meaning participants are followed forward in time.
What's involved
You would undergo smell testing and potentially an olfactory biopsy, which involves a simple brush technique in your nose. Some participants may also be asked to sniff an odor for about an hour.
Compensation
Not stated in the trial record.
Follow-up
The study is planned for completion over 5 years, during which changes in olfactory cells will be measured.

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NCT07021040

Olfactory Biopsies

Recruiting
NAAges 18+InterventionalBasic science
Duke University
~125 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:olfactory testingOdor stimulationOlfactory biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Transcription state changes in olfactory cells
Measured over study is planned for completion over 5 years
Alzheimer Disease
Smell Loss
Smell Dysfunction
1 sites across 1 states
North Carolina1
  • Bradley Goldstein, MD, PhD · PRINCIPAL_INVESTIGATOR · Duke University

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Eligibility criteria

Inclusion

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

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
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
  • Transcription state changes in olfactory cellsstudy is planned for completion over 5 years

    Using single cell RNA-sequencing, olfactory epithelial cell populations will be analyzed for changes in coherent gene expression programs from subjects in different environmental conditions.