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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06377241
Other study ID # 2023-1436
Secondary ID A536000SMPH/OPHT
Status Recruiting
Phase
First received
Last updated
Start date April 15, 2024
Est. completion date June 30, 2024

Study information

Verified date May 2024
Source University of Wisconsin, Madison
Contact Amy Remm
Phone 608-262-3377
Email amy.remm@wisc.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - 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 - Cohort 2: Cognitively unimpaired, a positive family history of MCI or AD, and MMSE = 26 - Cohort 3: Clinically diagnosed MCI due to AD, and an MMSE score > 22 and = 25 - Cohorts 1 and 2: proficient in independent use of mobile smart devices Exclusion Criteria: - 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 - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ScentAware
ScentAware is a smell test
UPSIT
UPSIT is a smell test

Locations

Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. One month post baseline
Primary 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. One month post baseline
Secondary Compare baseline ScentAware test scores between cohorts Baseline
Secondary Compare baseline UPSIT test scores between cohorts Baseline
Secondary Compare baseline ScentAware test scores to the retinal nerve fiber layer (RNFL) thickness Baseline
Secondary Compare baseline UPSIT test scores to the retinal nerve fiber layer (RNFL) thickness Baseline
Secondary Compare baseline ScentAware test scores to the ganglion cell layer (GCL) thickness Baseline
Secondary Compare baseline UPSIT test scores to the ganglion cell layer (GCL) thickness Baseline
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