Olfactory Biopsies for Loss of Smell
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how the olfactory lining in the nose functions and changes under various conditions. Researchers collect nasal tissue samples (olfactory biopsy) to gain insights into smell, especially in individuals with Alzheimer's and those with smell disorders. Individuals with Alzheimer's or a history of smell loss after an infection, such as COVID-19, may be suitable for this study. Participants should not have allergies to specific medications used during the procedure or active sinus problems. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on smell disorders and Alzheimer's.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that olfactory biopsies are safe?
Research has shown that taking a small tissue sample from the nose, known as an olfactory biopsy, is generally safe. Studies have found that this procedure does not affect a person's sense of smell. Specifically, one study found that individuals who underwent the biopsy had similar nasal function and smell as those who did not.
Some minor side effects have been reported, but they usually resolve quickly. For example, individuals might experience a brief backache or mild headache after the procedure. Overall, these studies suggest that the procedure is well-tolerated and does not negatively impact quality of life.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel method for diagnosing and understanding the loss of smell, especially in conditions like Alzheimer's and post-viral smell loss (such as COVID-19). Unlike traditional tests that only assess smell function, this method involves taking a small biopsy from the olfactory region of the nose using a nasal endoscope. This approach could provide deeper insights into the cellular changes associated with smell loss, potentially leading to better-targeted treatments in the future. By comparing groups with different causes of smell loss, the study aims to uncover unique patterns that could differentiate between types of smell dysfunction. This could pave the way for more personalized diagnostic and treatment strategies.
What evidence suggests that olfactory biopsies are effective for assessing loss of smell?
Research shows that taking small tissue samples from the nose can help researchers understand smell disorders. In past studies, samples from the part of the nose that detects smells have provided important information. The success rate for collecting this tissue ranges from 40% to 89%, demonstrating the feasibility of gathering and studying it. In this trial, participants will undergo olfactory biopsies to explore the causes and potential treatments for smell loss. People who lost their sense of smell due to upper respiratory infections like COVID-19 generally experience higher recovery rates compared to other causes. This suggests that this method could offer valuable insights into how smell loss occurs and how it might be treated.678910
Who Is on the Research Team?
Bradley Goldstein, MD, PhD
Principal Investigator
Duke University
Are You a Good Fit for This Trial?
This trial is for individuals with Alzheimer's Disease, Parosmia (distorted smell perception), or Anomia (difficulty naming odors). It involves those who have lost their sense of smell. Participants must be healthy enough to undergo a biopsy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Olfactory Function Assessment
Olfactory function is assessed using psychophysical testing such as the Smell Identification Test or Sniffin' Sticks Test
Biopsy Collection
Biopsies of the olfactory lining are obtained using a cytology brush or punch technique, potentially with odor stimulation
Analysis
Biopsies are processed for assays including histology, primary culture assays, flow cytometry assays, or transcriptomic profiling
Follow-up
Participants are monitored for any adverse effects post-biopsy and for data collection purposes
What Are the Treatments Tested in This Trial?
Interventions
- Olfactory Biopsy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborator