Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07021040

Analysis of Human Olfactory Biopsies in Alzheimer's Disease and Smell Loss

Led by Duke University · Updated on 2025-06-24

125

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

D

Duke University

Lead Sponsor

N

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying the function of the olfactory lining in the nose, which plays a key role in the sense of smell. This research includes both healthy people and those with conditions that might affect their sense of smell, such as Alzheimer's disease, inflammatory conditions, aging, or loss of smell after a viral infection. The goal is to understand the active cell types in the olfactory tissue under both healthy and disease conditions. Participants will undergo smell testing using recognized methods like the Smell Identification Test or Sniffin' Sticks Test. Biopsies of the olfactory lining will be collected either in a clinic setting using a nasal endoscope and cytology brush or during unrelated nasal surgeries in an operating room. Some participants may also be asked to sniff specific odors to stimulate olfactory cells before the biopsy. The collected tissue samples will be analyzed with various lab techniques to study cellular and genetic changes. During the study, participants will have their smell function measured and may undergo nasal biopsies with local anesthesia and nasal endoscopy. Researchers will collect data on transcription changes in olfactory cells over the planned five-year study period. The involvement includes clinical exams, smell tests, possible odor stimulation, and tissue collection. Safety and consent procedures are observed throughout, and the study will last up to the end date in 2028.

CONDITIONS

Brief Title

Olfactory Biopsies

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 80 years
  • Pre-clinical Alzheimer's disease with normal cognition but positive biomarkers
  • Confirmed diagnosis of symptomatic Alzheimer's disease or dementia able to consent
  • Adults age 18 or older with nasal or olfactory disorders
  • Patients undergoing unrelated endoscopic nasal surgery
  • Ability to provide legally effective consent
  • Able to complete nasal endoscopy procedure
Not Eligible

You will not qualify if you...

  • Advanced Alzheimer's disease or dementia
  • Known allergy to Afrin or Tetracaine HCL or related drugs
  • Active rhinosinusitis symptoms
  • History of sinonasal diseases that prevent biopsy (e.g., prior sinus or skull base surgery, sinonasal tumors, olfactory cleft polyps)
  • Parkinson's disease
  • Unable or unwilling to complete nasal endoscopy procedure
  • Unable to read or speak English
  • Unable to provide legally effective consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Olfactory Testing and Biopsy

Duration - Single day procedure

Participants undergo smell testing and may receive an olfactory biopsy using a nasal endoscope in the clinic or operating room. Some participants may sniff an odor substance to stimulate olfactory cells before biopsy.

1 visit (in-person)

Laboratory Analysis

Duration - Ongoing during study duration

Biopsy samples are processed for various laboratory assays including histology, primary culture assays, flow cytometry, and transcriptomic profiling to analyze olfactory cell activity.

No participant visits required

Trial Site Locations

Total: 1 location

1

Duke University Health Center

Durham, North Carolina, United States, 27710

Actively Recruiting

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Research Team

M

Maria J Manson, MBA

B

Bradley J Goldstein, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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