Olfactory Biopsies
Recruiting · NCT07021040 · Interventional (participants receive a specific treatment) · Lead sponsor: Duke University
View the official record on ClinicalTrials.gov →Interventions studied
Odor stimulationOlfactory biopsyolfactory testing
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- Duke University Health Center - Durham, North Carolina, United States