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Recruiting
NCT07021040
Olfactory Biopsies
Conditions: Alzheimer Disease, Smell Loss, Smell Dysfunction
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 125
Sponsor: Duke University
Location: Duke University Health Center Durham North Carolina
Summary
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.
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
Source: ClinicalTrials.gov (NCT07021040). StuddyBuddy aggregates publicly available trial information.