ScentAware and OCT in MCI vs HC

University of Wisconsin, Madison20 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Alzheimer Disease, Early Onset

Interventions

ScentAwareDEVICE

ScentAware is a smell test

UPSITDEVICE

UPSIT is a smell test

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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: 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 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)

Locations (1)

University of Wisconsin

Madison, Wisconsin, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline

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

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

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

Data from ClinicalTrials.gov

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