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

Lilly

Status: Not yet enrolling

Conditions: Memory Disorders; Cognitive Dysfunction

Treatments: Other: Retinal scan; Other: Blood test

Study type: Observational

Funder types: Industry

Identifiers

NCT07254234

27414

H7I-MC-S035 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

200 participants in 1 patient group

Participants with Memory Complaints or Mild Cognitive Impairment (MCI)

Description:

Retinal scan and blood biomarker testing

Treatment:

Other: Blood test

Other: Retinal scan