A Study of Retinal Imaging to Detect Abnormal Protein Deposits Associated With Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Retinal scan, Blood test.
- Who it may be relevant to
- Registry conditions: Cognitive Dysfunction, Memory Disorders. Basic parameters: from 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Arab Emirates
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Other Retinal scan
Detailed image of the retina. - Other Blood 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.
Primary outcome measures
- Percentage of Participants with the Same Results on the Blood Test and Retinal Scan [Time frame: Day 1]
Secondary outcome measures (1)
- Percentage of Participants who Report High or Moderate Satisfaction with Retinal Scan [Time frame: Day 1]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Arab Emirates · 1 center
- Cleveland Clinic Abu Dhabi — Abu Dhabi
Identifiers
NCT: NCT07254234 · 27414 · H7I-MC-S035