ScentAware and OCT in MCI vs HC

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-15

Study Completion Date

2024-06-05

Brief Summary

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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

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Detailed Description

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Conditions

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Alzheimer Disease, Early Onset

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort 1

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

ScentAware

Intervention Type DEVICE

ScentAware is a smell test

UPSIT

Intervention Type DEVICE

UPSIT is a smell test

Cohort 2

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

ScentAware

Intervention Type DEVICE

ScentAware is a smell test

UPSIT

Intervention Type DEVICE

UPSIT is a smell test

Cohort 3

Mild cognitive impairment due to Alzheimer's disease

ScentAware

Intervention Type DEVICE

ScentAware is a smell test

UPSIT

Intervention Type DEVICE

UPSIT is a smell test

Interventions

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ScentAware

ScentAware is a smell test

Intervention Type DEVICE

UPSIT

UPSIT is a smell test

Intervention Type DEVICE

Eligibility Criteria

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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)

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes