[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100594560":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":35,"centralContacts":39,"locations":49,"responsibleParty":70,"collaborators":72,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":25,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":25,"enrollmentInfo":85,"targetDuration":25,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":96,"overallStatus":52,"whyStopped":25,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Duke University","OTHER",[8,15],{"label":9,"type":6,"description":10,"interventionNames":11},"Alzheimer's study","Olfactory function will be assessed using the Smell Identification Test (SIT, Sensonics, Inc) or Sniffin' Sticks Test. Using topical intranasal decongestion\u002Fanesthetic (oxymetazoline\u002Flidocaine), a cytology brush biopsy will be obtained from the olfactory cleft region of the nose in clinic exam room using a nasal endoscope.",[12,13,14],"Diagnostic Test: olfactory testing","Other: Odor stimulation","Procedure: Olfactory biopsy",{"label":16,"type":6,"description":17,"interventionNames":18},"Act-seq study or Non-AD controls","Olfactory function will be measured using established psychophysical testing via the Smell Identification Test or Sniffin' Sticks. Researchers will obtain biopsies from (1) normosmic subjects with or without odor stimulation, and (2) hyposmic subjects with history of upper respiratory infection (URI) as likely cause of the smell loss (such as COVID19) with or without odor stimulation.",[12,13,14],[20,26,30],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","olfactory testing","Patients will undergo smell testing, using the Smell Identification Test (Sensonics), a validated widely-used 40-item \"scratch-and-sniff\" style psychophysical test to determine olfactory function.",[16,9],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Odor stimulation","subset of patients will be asked to sniff a specific odor for about an hour, using commercially available \"odor pens\" (Sniffin' Sticks or Sensonics). These odor pens are widely used for olfactory training therapy, a treatment designed to help people with some forms of smell loss; they are also used in psychophysical olfactory testing.",[16,9],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":25},"PROCEDURE","Olfactory biopsy","Biopsy involves a simple cytology brush technique of the lining of the nose in a region called the olfactory cleft, using a nasal endoscope, and can be done in clinic or in the operating room at the time of a nasal surgery. Topical oxymetazoline and tetracaine spray is applied to the nasal cavity, a rigid nasal endoscopy (0-degree 4 mm endoscope, Karl Storz) is performed to visualize the olfactory cleft, and a small nasal cytology brush biopsy (Hobbs Medical)is performed by swabbing and rotating brush gently in the olfactory cleft. Cytology sample is placed into a buffer (Hibernate-E, Thermo Fisher)on ice for transport to the research lab.",[16,9],[36],{"name":37,"affiliation":5,"role":38},"Bradley Goldstein, MD, PhD","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":25,"email":44},"Maria J Manson, MBA","CONTACT","(919) 684-0525","maria.manson@duke.edu",{"name":46,"role":42,"phone":47,"phoneExt":25,"email":48},"Bradley J Goldstein, MD, PhD","(919) 684 3834","bradley.goldstein@duke.edu",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Duke University Health Center","RECRUITING","Durham","North Carolina","27710","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-78.89862,35.99403,{"lat":62,"lon":61},[65,67,69],{"name":66,"role":42,"phone":47,"phoneExt":25,"email":48},"Bradley J Goldstein, MD",{"name":41,"role":42,"phone":68,"phoneExt":25,"email":44},"(919)684-0625",{"name":46,"role":38,"phone":25,"phoneExt":25,"email":25},{"type":71,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[73],{"name":74,"class":75},"National Institute on Deafness and Other Communication Disorders (NIDCD)","NIH","100594560","olfactory-biopsies-100594560",false,"NCT07021040","Olfactory Biopsies","Analysis of Human Olfactory Biopsies","Group 1: Alzheimer's study\n\nInclusion Criteria:\n\n* Between the ages of 18 and 80\n* Pre-clinical AD (this cohort consists of subjects who have normal cognitive testing and function, but have positive AD biomarkers);\n* Symptomatic AD (a confirmed diagnosis of Alzheimer's or dementia who are capable of understanding and signing the consent document)\n\nExclusion Criteria:\n\n* Advanced Alzheimer's\u002Fdementia\n* Self-reported or known allergy to Afrin or Tetracain HCL (or related class of drugs)\n* Active Rhinosinusitis symptoms\n* 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)\n* Parkinson's disease\n* Unable or willing to complete the nasal endoscopy procedure.\n* Unable to read or speak English\n* Unable to provide legally effective consent\n\nGroup 2: Act-seq study or Non-AD controls\n\nInclusion Criteria:\n\n* Age 18 years or older\n* Patients being seen for rhinology or olfactory disorders\n* Patients having unrelated endoscopic nasal surgery\n\nExclusion Criteria:\n\n* Self-reported or known allergy to Afrin or Tetracain HCL (or related class of drugs)\n* Unable or willing to complete the nasal endoscopy procedure\n* Unable to read or speak English\n* Unable to provide legally effective consent","ALL","18 Years",{"count":86,"type":87},125,"ESTIMATED","INTERVENTIONAL",[90],"NA","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.\n\nThe purpose of this study is to collect tissue from the nasal cavity.",[93,94,95],"Alzheimer Disease","Smell Loss","Smell Dysfunction",[97,98,99],"act-seq","nasal biopsy","RNA-seq","2026-06-11",{"date":102,"type":103},"2026-06-12","ACTUAL",{"date":105,"type":103},"2025-01-06",{"date":107,"type":87},"2029-07-31",{"name":5,"class":6},1]