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

NCT07254234 | Not Yet Recruiting

• 2 other identifiers: 27414H7I-MC-S035
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Dysfunction; Memory Disorders

Outcome Measures

Primary Outcomes (1)

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

  Day 1

Secondary Outcomes (1)

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

  Day 1

Study Arms (1)

Participants with Memory Complaints or Mild Cognitive Impairment (MCI)

Retinal scan and blood biomarker testing

Other: Retinal scan; Other: Blood test

Interventions

Retinal scan OTHER

Detailed image of the retina.

Participants with Memory Complaints or Mild Cognitive Impairment (MCI)

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.

Participants with Memory Complaints or Mild Cognitive Impairment (MCI)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Emiratis age 55 or older with mild memory complaints or MCI who are otherwise healthy.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Cleveland Clinic Abu Dhabi

Abu Dhabi, United Arab Emirates

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Memory Disorders

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: November 28, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)