Alzheimer DiseaseNCT07021040
Olfactory Biopsies
A study testing olfactory testing, Odor stimulation and Olfactory biopsy in people with Alzheimer Disease and Smell Loss, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease, Smell Loss, Smell Dysfunction
- What is being tested?
- olfactory testing, Odor stimulation and Olfactory biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2025to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Age 18 years or older
- Patients being seen for rhinology or olfactory disorders
- Patients having unrelated endoscopic nasal surgery
Who cannot join
- 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.
Show all 13Show fewer
- Unable to read or speak English
- Unable to provide legally effective consent
- Group 2: Act-seq study or Non-AD controls
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Health Center
Durham, North Carolina, 27710
Bradley J Goldstein, MD, (919) 684 3834, bradley.goldstein@duke.edu
Maria J Manson, MBA, (919)684-0625, maria.manson@duke.edu
About this study
Official title: Analysis of Human Olfactory Biopsies
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.
Read the detailed description
The purpose of this study is to analyze cell populations active in human olfactory tissue in health and disease. This is a prospective study. Healthy participants or participants with known disease processes that may impact olfaction, such as Alzheimer's, inflammatory conditions, aging, or post-viral smell loss, will be included. Olfaction will be measured using standard psychophysical testing. 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.
- Conditions
- Alzheimer Disease, Smell Loss, Smell Dysfunction
- Being tested
- olfactory testing, Odor stimulation, Olfactory biopsy
- Keywords
- act-seq, nasal biopsy, RNA-seq
- Medical subject headings
- Alzheimer Disease, Anosmia, Olfaction Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olfactory testingDiagnostic test
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.
Odor stimulationOther
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.
Olfactory biopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's study | Other | Olfactory function will be assessed using the Smell Identification Test (SIT, Sensonics, Inc) or Sniffin' Sticks Test. Using topical intranasal decongestion/anesthetic (oxymetazoline/lidocaine), a cytology brush biopsy will be obtained from the olfactory cleft region of the nose in clinic exam room using a nasal endoscope. Receives: Diagnostic Test: olfactory testing; Other: Odor stimulation; Procedure: Olfactory biopsy |
| Act-seq study or Non-AD controls | Other | 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. Receives: Diagnostic Test: olfactory testing; Other: Odor stimulation; Procedure: Olfactory biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transcription state changes in olfactory cells
Using single cell RNA-sequencing, olfactory epithelial cell populations will be analyzed for changes in coherent gene expression programs from subjects in different environmental conditions.
Measured: study is planned for completion over 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start6 Jan 2025
- Primary completion30 Apr 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Bradley Goldstein, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07021040
- Sponsor's protocol ID
- Pro00116591
- Other IDs
- 1R01DC021422-01A1
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Human Olfactory Biopsies
- ClinicalTrials.gov ID
- NCT07021040
- Acronym / sponsor ID
- Pro00116591
- Conditions
- Alzheimer Disease, Smell Loss, Smell Dysfunction
- Keywords
- act-seq, nasal biopsy, RNA-seq
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The purpose of this study is to analyze cell populations active in human olfactory tissue in health and disease. This is a prospective study. Healthy participants or participants with known disease processes that may impact olfaction, such as Alzheimer's, inflammatory conditions, aging, or post-viral smell loss, will be included. Olfaction will be measured using standard psychophysical testing. 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's study | Other | Diagnostic Test: olfactory testing, Other: Odor stimulation, Procedure: Olfactory biopsyOlfactory function will be assessed using the Smell Identification Test (SIT, Sensonics, Inc) or Sniffin' Sticks Test. Using topical intranasal decongestion/anesthetic (oxymetazoline/lidocaine), a cytology brush biopsy will be obtained from the olfactory cleft region of the nose in clinic exam room using a nasal endoscope. |
| Act-seq study or Non-AD controls | Other | Diagnostic Test: olfactory testing, Other: Odor stimulation, Procedure: Olfactory biopsyOlfactory 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
- Age 18 years or older
- Patients being seen for rhinology or olfactory disorders
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olfactory testingPatients 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. | Diagnostic test | Act-seq study or Non-AD controls, Alzheimer's study |
| Odor stimulationsubset 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. | Other | Act-seq study or Non-AD controls, Alzheimer's study |
| Olfactory biopsyBiopsy 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. | Procedure or surgery | Act-seq study or Non-AD controls, Alzheimer's study |
Primary outcome
Transcription state changes in olfactory cells
Time frame: study is planned for completion over 5 years
Using single cell RNA-sequencing, olfactory epithelial cell populations will be analyzed for changes in coherent gene expression programs from subjects in different environmental conditions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bradley Goldstein, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olfactory testing, Odor stimulation and Olfactory biopsy in people with Alzheimer Disease and Smell Loss, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria J Manson, MBA ((919) 684-0525, maria.manson@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transcription state changes in olfactory cells (time frame: study is planned for completion over 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.