Alzheimer Disease, Early OnsetNCT06377241
ScentAware and OCT in MCI vs HC
An observational study of Alzheimer Disease, Early Onset, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn whether a new smell test works as well as the standard clinical smell test, if there is a link between sense of smell and variations in the retina, and if these results could be used as a way to identify early stages of Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Early Onset
- What is being tested?
- ScentAware and UPSIT
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 5 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (50-80 years of age) in three cohorts: Cohort 1: 10 participants cognitively unimpaired with no family history of AD Cohort 2: 10 participants cognitively unimpaired with a family history of AD Cohort 3: 10 participants with clinically diagnosed MCI or from the Wisconsin ADRC registry and clinically diagnosed or self-reported MCI
Who may be able to join
- Adults who are ≥ 50 and ≤ 80 years of age
- Fluent in English
- Able to provide written consent
- Able to complete a 2.5-3-hour clinical visit, including sitting for spectral domain optical coherence tomography (SD-OCT) imaging for 30 minutes and taking cognitive and olfactory tests for 90-120 minutes
- Cognitive Ability and Family History of Alzheimer's Disease/Mild Cognitive Impairment (AD/MCI):
- Cohort 1: Cognitively unimpaired, no family history of MCI or AD, and MMSE ≥ 26
Show all 11Show fewer
- Cohort 2: Cognitively unimpaired, a positive family history of MCI or AD, and MMSE ≥ 26
- Cohort 3: An MMSE score > 22 and ≤ 25 and either
- Clinically diagnosed MCI due to AD
- A participant in a Wisconsin ADRC research registry with either clinically diagnosed MCI or self-reported MCI
- Cohorts 1 and 2: proficient in independent use of mobile smart devices
Who cannot join
- A history of significant ocular or nasal trauma that required medical/surgical intervention
- A history of intraocular surgery except cataract extraction
- A cataract extraction within 3 months prior to enrollment
- Diagnosis of visually significant intraocular disease (such as late-stage age-related macular degeneration, glaucoma, or other optic nerve conditions related to brain tumor or multiple sclerosis), drug related vision loss or retinal damage
- Optic neuritis on both eyes
- Current use of medications that may interfere with olfactory functions
Show all 10Show fewer
- Current use of hydroxychloroquine and tamoxifen, which are known to cause retinal toxicity that may confound OCT interpretation
- A history of recurrent or chronic oto-pharyngeal-laryngeal (ORL) disease (such as chronic rhinitis, nasal polyposis, or sinus disease), head trauma, toxic exposures, upper respiratory infections at time of assessment
- A family history or diagnosis of other neurodegenerative diseases (e.g., multiple sclerosis, Parkinson's disease, Huntington's disease) or conditions that, in the opinion of the Investigators, may affect cognitive or olfactory functions
- Olfactory loss due to COVID (current olfactory loss and/or temporary loss that has been regained)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Proof-of-concept Pilot Study to Determine the Efficacy of SensifyAware and Retinal Imaging in Differentiating Mild Cognitive Impairment (MCI) From Cognitively Unimpaired Controls (HC)
The goal of this clinical trial is to learn whether a new smell test works as well as the standard clinical smell test, if there is a link between sense of smell and variations in the retina, and if these results could be used as a way to identify early stages of Alzheimer's disease. The main questions it aims to answer are:
- Whether the test is as effective and reliable as the standard test
- Whether there is a link between the results of the smell test and the structure of the back of the eye
Participants will:
- complete a short questionnaire
- have pictures of the inside of their eyes taken
- perform two smell tests
- Conditions
- Alzheimer Disease, Early Onset
- Being tested
- ScentAware, UPSIT
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScentAwareDevice
ScentAware is a smell test
UPSITDevice
UPSIT is a smell test
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | No cognitive impairment, and no family history of Alzheimer's disease Receives: Device: ScentAware; Device: UPSIT | |
| Cohort 2 | No cognitive impairment, with a family history of Alzheimer's disease Receives: Device: ScentAware; Device: UPSIT | |
| Cohort 3 | Mild cognitive impairment due to Alzheimer's disease Receives: Device: ScentAware; Device: UPSIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare test scores of ScentAware olfactory test to the scores of the University of Pennsylvania Smell Identification Test (UPSIT) olfactory test in a clinical setting
Performance of ScentAware and UPSIT odor identification score will be performed using Receiver Operating Characteristic (ROC) Curve analysis. Area under the ROC curve (AUC) will be used to determine diagnostic accuracy. An AUC ranges from 0 to 1. Higher AUC values indicate better sensitivity.
Measured: Baseline
Compare ScentAware test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently
Performance of ScentAware and UPSIT odor identification score will be performed using Receiver Operating Characteristic (ROC) Curve analysis. Area under the ROC curve (AUC) will be used to determine diagnostic accuracy. An AUC ranges from 0 to 1. Higher AUC values indicate better sensitivity.
Measured: One month post baseline
Compare UPSIT test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently
Performance of ScentAware and UPSIT odor identification score will be performed using Receiver Operating Characteristic (ROC) Curve analysis. Area under the ROC curve (AUC) will be used to determine diagnostic accuracy. An AUC ranges from 0 to 1. Higher AUC values indicate better sensitivity.
Measured: One month post baseline
Secondary outcomes (6)
Compare baseline ScentAware test scores between cohorts
Measured: Baseline
Compare baseline UPSIT test scores between cohorts
Measured: Baseline
Compare baseline ScentAware test scores to the retinal nerve fiber layer (RNFL) thickness
Measured: Baseline
Compare baseline UPSIT test scores to the retinal nerve fiber layer (RNFL) thickness
Measured: Baseline
Compare baseline ScentAware test scores to the ganglion cell layer (GCL) thickness
Measured: Baseline
Compare baseline UPSIT test scores to the ganglion cell layer (GCL) thickness
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start15 Apr 2024
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanbrita Mondal, OD, Principal investigator, University of Wisconsin, MadisonKathleen Schildroth, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377241
- Sponsor's protocol ID
- 2023-1436
- Other IDs
- A536000, SMPH/OPHTHAL&VIS SCI/GEN, Protocol Version 9/20/2024
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2024
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof-of-concept Pilot Study to Determine the Efficacy of SensifyAware and Retinal Imaging in Differentiating Mild Cognitive Impairment (MCI) From Cognitively Unimpaired Controls (HC)
- ClinicalTrials.gov ID
- NCT06377241
- Acronym / sponsor ID
- 2023-1436
- Conditions
- Alzheimer Disease, Early Onset
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 22 Apr 2024 (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.
The goal of this clinical trial is to learn whether a new smell test works as well as the standard clinical smell test, if there is a link between sense of smell and variations in the retina, and if these results could be used as a way to identify early stages of Alzheimer's disease. The main questions it aims to answer are:
- Whether the test is as effective and reliable as the standard test
- Whether there is a link between the results of the smell test and the structure of the back of the eye
Participants will:
- complete a short questionnaire
- have pictures of the inside of their eyes taken
- perform two smell tests
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: ScentAware, Device: UPSITNo cognitive impairment, and no family history of Alzheimer's disease |
| Cohort 2 | – | Device: ScentAware, Device: UPSITNo cognitive impairment, with a family history of Alzheimer's disease |
| Cohort 3 | – | Device: ScentAware, Device: UPSITMild cognitive impairment due to Alzheimer's disease |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (50-80 years of age) in three cohorts: Cohort 1: 10 participants cognitively unimpaired with no family history of AD Cohort 2: 10 participants cognitively unimpaired with a family history of AD Cohort 3: 10 participants with clinically diagnosed MCI or from the Wisconsin ADRC registry and clinically diagnosed or self-reported MCI
Key inclusion criteria (11 listed)
- Adults who are ≥ 50 and ≤ 80 years of age
- Fluent in English
- Able to provide written consent
- Able to complete a 2.5-3-hour clinical visit, including sitting for spectral domain optical coherence tomography (SD-OCT) imaging for 30 minutes and taking cognitive and olfactory tests for 90-120 minutes
- Cognitive Ability and Family History of Alzheimer's Disease/Mild Cognitive Impairment (AD/MCI):
Key exclusion criteria (10 listed)
- A history of significant ocular or nasal trauma that required medical/surgical intervention
- A history of intraocular surgery except cataract extraction
- A cataract extraction within 3 months prior to enrollment
- Diagnosis of visually significant intraocular disease (such as late-stage age-related macular degeneration, glaucoma, or other optic nerve conditions related to brain tumor or multiple sclerosis), drug related vision loss or retinal damage
- Optic neuritis on both eyes
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 |
|---|---|---|
| ScentAwareScentAware is a smell test | Device | Cohort 1, Cohort 2, Cohort 3 |
| UPSITUPSIT is a smell test | Device | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Compare test scores of ScentAware olfactory test to the scores of the University of Pennsylvania Smell Identification Test (UPSIT) olfactory test in a clinical setting
Time frame: Baseline
Performance of ScentAware and UPSIT odor identification score will be performed using Receiver Operating Characteristic (ROC) Curve analysis. Area under the ROC curve (AUC) will be used to determine diagnostic accuracy. An AUC ranges from 0 to 1. Higher AUC values indicate better sensitivity.
Compare ScentAware test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently
Time frame: One month post baseline
Performance of ScentAware and UPSIT odor identification score will be performed using Receiver Operating Characteristic (ROC) Curve analysis. Area under the ROC curve (AUC) will be used to determine diagnostic accuracy. An AUC ranges from 0 to 1. Higher AUC values indicate better sensitivity.
Compare UPSIT test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently
Time frame: One month post baseline
Performance of ScentAware and UPSIT odor identification score will be performed using Receiver Operating Characteristic (ROC) Curve analysis. Area under the ROC curve (AUC) will be used to determine diagnostic accuracy. An AUC ranges from 0 to 1. Higher AUC values indicate better sensitivity.
6 secondary outcomes
Compare baseline ScentAware test scores between cohorts
Time frame: Baseline
Compare baseline UPSIT test scores between cohorts
Time frame: Baseline
Compare baseline ScentAware test scores to the retinal nerve fiber layer (RNFL) thickness
Time frame: Baseline
Compare baseline UPSIT test scores to the retinal nerve fiber layer (RNFL) thickness
Time frame: Baseline
Compare baseline ScentAware test scores to the ganglion cell layer (GCL) thickness
Time frame: Baseline
Compare baseline UPSIT test scores to the ganglion cell layer (GCL) thickness
Time frame: Baseline
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
Related trials for Alzheimer Disease, Early Onset
RecruitingPhase 1
A Study to Evaluate the Safety and Tolerability of ALN-APP in Patients With EOAD
Early-Onset Alzheimer Disease
Active, not recruitingPhase 1
Study of Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of NIO752 in Early Alzheimer's Disease Participants
Alzheimer Disease, Mild Cognitive Impairment
RecruitingPhase 1/2
Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease
Alzheimer Disease, Alzheimer Disease, Early Onset
RecruitingPhase 2/3
A Study of Donanemab, RG6289, or the Combination of Donanemab and RG6289 in Presenilin 1 (PSEN1) E280A Mutation Carriers for the Treatment of Autosomal-Dominant Alzheimer's Disease
Autosomal Dominant Alzheimers Disease, Early Onset Alzheimer Disease
Enrolling by invitation
Cholinergic Deep Brain Stimulation for Alzheimer's Disease
Alzheimer Disease, Early Onset, Dementia
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. This study is not recruiting at the moment.
Sanbrita Mondal, OD principal investigator
University of Wisconsin, Madison
Kathleen Schildroth, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, Early Onset, run by University of Wisconsin, Madison 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 11 inclusion and 10 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: stopped early, as of the sponsor's last update on 23 Apr 2025. 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?
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare test scores of ScentAware olfactory test to the scores of the University of Pennsylvania Smell Identification Test (UPSIT) olfactory test in a clinical setting (time frame: Baseline). The study lists 3 primary outcomes in all. 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 23 Apr 2025.