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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07254234
Enrollment
200
Registered
2025-11-28
Start date
2025-12-31
Completion date
2026-08-31
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction, Memory Disorders

Brief summary

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.

Interventions

OTHERRetinal scan

Detailed image of the retina.

OTHERBlood test

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.

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of Participants with the Same Results on the Blood Test and Retinal ScanDay 1

Secondary

MeasureTime frameDescription
Percentage of Participants who Report High or Moderate Satisfaction with Retinal ScanDay 1Measured 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.

Countries

United Arab Emirates

Contacts

Primary ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com1-317-615-4559
Backup ContactPhysicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026