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NCT Number: NCT07254234

A Study of Retinal Imaging to Detect Abnormal Protein Deposits Associated With Alzheimer's Disease

The purpose of this study is to test the use of a screening tool to detect changes in the eye that are associated with Alzheimer's disease in adult participants with memory issues. For each participant, the study will last up to one month and requires one visit to the research site.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Abu Dhabi

Abu Dhabi, United Arab Emirates

Location contact

Usman Moghal

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who are overtly healthy as determined by medical evaluation, including medical history and physical examination.
  • Have mild memory complaints or a diagnosis of mild cognitive impairment.
  • Have undergone genotyping for apolipoprotein E (APOE) and are willing to make results available to the investigator.
  • Montreal Cognitive Assessment (MoCA) score of greater than or equal to 22 and less than or equal to 28.

Exclusion criteria

  • Have any medical condition that, in the opinion of the investigator, would be a contraindication to participation in the study.
  • Have an existing diagnosis of AD or other dementia.
  • Have contradictions to or an allergy to the ophthalmic dilating agents.
  • Have known diagnosis of severe glaucoma or severe cataracts; have a significant refractive error (more than 12 diopters [D] of spherical equivalent refraction); or have any ocular media opacity that prevents imaging of the retina (that is, severe cataract). Note: mild to moderate cataracts or vision correction with glasses or contact lenses are not exclusion criteria.
  • Current or previous treatment with anti-amyloid medications.
  • Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Treatment and study plan

Retinal scan

Other

Detailed image of the retina.

Blood Test

Other

Sample will be used to test for a specific form of a protein in the blood to learn more about early detection of Alzheimer's disease.

Primary outcomes

  1. Percentage of Participants with the Same Results on the Blood Test and Retinal Scan

    Time frame: Day 1

Secondary outcomes

  1. Percentage of Participants who Report High or Moderate Satisfaction with Retinal Scan

    Time frame: Day 1

    Measured by 5-item retinal scan feedback survey. Participants rate their experience with the retinal scan on a 5-item Likert scale that ranges from "Strongly Disagree" to "Strongly Agree." Higher scores are better.

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Exploratory Study to Assess Utility of RetiSpec Artificial Intelligence Powered Retinal Imaging Solution in Detecting Amyloid Pathology in United Arab Emirates Nationals With Mild Impairment of Cognition

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 28, 2025
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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