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ScentAware and OCT in MCI vs HC

Recruiting
50 - 80 years of age
Both
Phase N/A

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Overview

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

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 details

Alzheimer Disease, Early Onset

NCT06377241

University of Wisconsin, Madison

8 June 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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