ScentAware and OCT in MCI vs HC

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

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease, Early Onset
• Intervention / Treatment: Device: ScentAware; Device: UPSIT

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Amy Remm; Phone Number: 608-262-3377; Email: amy.remm@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • Recruiting
      • University of Wisconsin
      • Contact: Amy Remm; Phone Number: 608-262-3377; Email: amy.remm@wisc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; No cognitive impairment, and no family history of Alzheimer's disease	Device: ScentAware; ScentAware is a smell test; Device: UPSIT; UPSIT is a smell test
Cohort 2; No cognitive impairment, with a family history of Alzheimer's disease	Device: ScentAware; ScentAware is a smell test; Device: UPSIT; UPSIT is a smell test
Cohort 3; Mild cognitive impairment due to Alzheimer's disease	Device: ScentAware; ScentAware is a smell test; Device: UPSIT; UPSIT is a smell test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Time Frame
Compare baseline ScentAware test scores between cohorts	Baseline
Compare baseline UPSIT test scores between cohorts	Baseline
Compare baseline ScentAware test scores to the retinal nerve fiber layer (RNFL) thickness	Baseline
Compare baseline UPSIT test scores to the retinal nerve fiber layer (RNFL) thickness	Baseline
Compare baseline ScentAware test scores to the ganglion cell layer (GCL) thickness	Baseline
Compare baseline UPSIT test scores to the ganglion cell layer (GCL) thickness	Baseline

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Investigators: Principal Investigator: Sanbrita Mondal, OD, University of Wisconsin, Madison; Principal Investigator: Kathleen Schildroth, MD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 22, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 2023-1436; A536000 (Other Identifier: UW- Madison); SMPH/OPHTHAL&VIS SCI/GEN (Other Identifier: UW- Madison); Protocol Version 2/23/2024 (Other Identifier: UW Madison)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No