RightFit
RecruitingNot applicable

Olfactory Biopsies

Analysis of Human Olfactory Biopsies

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Biopsies of the olfactory lining in the nasal cavity may be obtained in the otolaryngology clinic or the operating room, if the patient is having an unrelated endoscopic nasal surgery, and may be obtained using a punch technique or a cytology brush."
  • "Before biopsies, some patients may be asked to sniff an odor substance (such as lavender, mint, citrus, or cloves) briefly, to stimulate olfactory cells."
  • "Biopsies will be processed for assays in the PI's lab, including histology, primary culture assays, flow cytometry assays, or transcriptomic profiling."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects tissue from inside the nose to learn about the lining that helps people smell. It studies this lining in health and disease, with groups for people with signs of Alzheimer's disease and people getting care for nose or smell problems or having unrelated nasal surgery.

This research study aims to investigate the function of the olfactory lining in the nasal cavity and its potential alterations in both healthy and diseased conditions. The olfactory lining is involved in the sense of smell. The purpose of this study is to collect tissue from the nasal cavity.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Alzheimer's group: Ages 18 to 80.
  • Alzheimer's group: Normal thinking tests and daily function, but tests show signs of Alzheimer's disease; or a confirmed diagnosis of Alzheimer's or dementia with the ability to understand and sign the consent form.
  • Act-seq or non-Alzheimer's comparison group: Age 18 or older.
  • Act-seq or non-Alzheimer's comparison group: Getting care for nose or smell problems, or having unrelated nasal surgery using a thin viewing tube.

Who can't join

  • Both groups: Allergy to Afrin, tetracaine HCL, or similar medicines.
  • Both groups: Cannot or will not complete an exam inside the nose using a thin viewing tube.
  • Both groups: Cannot read or speak English.
  • Both groups: Cannot give legally valid consent to join.
  • Alzheimer's group: Advanced Alzheimer's disease or dementia.
  • Alzheimer's group: Current symptoms of swelling or infection in the nose and sinuses.
  • Alzheimer's group: Nose or sinus conditions that prevent safe tissue collection, such as certain past surgeries, tumors, or growths near the smell lining.
  • Alzheimer's group: Parkinson's disease.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC