Clinical trial NCT06377241: ScentAware and OCT in MCI vs HC
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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Alzheimer Disease, Early Onset
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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


Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: Baseline
measure: Compare ScentAware test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently
timeFrame: One month post baseline
measure: Compare UPSIT test results conducted with support from clinical staff to the test results when ScentAware test was self-administered independently
timeFrame: One month post baseline
Secondary outcomes:
measure: Compare baseline ScentAware test scores between cohorts
timeFrame: Baseline
measure: Compare baseline UPSIT test scores between cohorts
timeFrame: Baseline
measure: Compare baseline ScentAware test scores to the retinal nerve fiber layer (RNFL) thickness
timeFrame: Baseline
measure: Compare baseline UPSIT test scores to the retinal nerve fiber layer (RNFL) thickness
timeFrame: Baseline
measure: Compare baseline ScentAware test scores to the ganglion cell layer (GCL) thickness
timeFrame: Baseline
measure: Compare baseline UPSIT test scores to the ganglion cell layer (GCL) thickness
timeFrame: Baseline
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Sanbrita Mondal, OD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin, Madison
name: Kathleen Schildroth, MD
role: PRINCIPAL_INVESTIGATOR
References: