ScentAware and OCT in MCI vs HC

NCT06377241 | Terminated DMC FDA Device

• 4 other identifiers: 2023-1436A536000SMPH/OPHTHAL&VIS SCI/GENProtocol Version 9/20/2024
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Alzheimer Disease, Early Onset

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Study Arms (3)

Cohort 1

No cognitive impairment, and no family history of Alzheimer's disease

Device: ScentAware; Device: UPSIT

Cohort 2

No cognitive impairment, with a family history of Alzheimer's disease

Device: ScentAware; Device: UPSIT

Cohort 3

Mild cognitive impairment due to Alzheimer's disease

Device: ScentAware; Device: UPSIT

Interventions

ScentAware DEVICE

ScentAware is a smell test

Cohort 1; Cohort 2; Cohort 3

UPSIT DEVICE

UPSIT is a smell test

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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 or from the Wisconsin ADRC registry and clinically diagnosed or self-reported MCI

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sanbrita Mondal, OD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

• Kathleen Schildroth, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 22, 2024
• Study Start: April 15, 2024
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: April 23, 2025

Record last verified: 2025-04

Locations

US (1)