A Study of Retinal Imaging to Detect Abnormal Protein Deposits Associated With Alzheimer's Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55+
SponsorEli Lilly and Company
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Emiratis age 55 or older with mild memory complaints or MCI who are otherwise healthy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Retinal scan
Other interventionDetailed image of the retina.
Blood test
Other interventionSample 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Participants with Memory Complaints or Mild Cognitive Impairment (MCI)2 interventions
Trial outcomes
Primary outcomes
1
Percentage of Participants with the Same Results on the Blood Test and Retinal Scan
Time frame
Day 1Secondary outcomes
1
Percentage of Participants who Report High or Moderate Satisfaction with Retinal Scan
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.
Time frame
Day 1Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov