ScentAware and OCT in MCI vs HC

Alzheimer Disease, Early Onset Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06377241
• Other study ID #: 2023-1436
• Secondary ID: A536000SMPH/OPHT
• Status: Recruiting
• 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
• 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)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Early Onset

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