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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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
Study Overview
Brief 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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
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
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.
Secondary Outcomes
- Compare baseline UPSIT test scores to the ganglion cell layer (GCL) thickness(Baseline)
- Compare baseline ScentAware test scores to the retinal nerve fiber layer (RNFL) thickness(Baseline)
- Compare baseline UPSIT test scores between cohorts(Baseline)
- Compare baseline UPSIT test scores to the retinal nerve fiber layer (RNFL) thickness(Baseline)
- Compare baseline ScentAware test scores between cohorts(Baseline)
- Compare baseline ScentAware test scores to the ganglion cell layer (GCL) thickness(Baseline)