A Study to Gain Clinical Validation of an Automated Retinal Image Analysis System (EyeQuant) with Vascular Biomarkers to Indicate Cognitive Decline
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 20-007289
NCT ID: NCT04567745
About this study
This study aims to provide clinical validation of EyeQuant, a fully automated retinal image analysis system for computation of vascular biomarkers indicative of cognitive disorders, using retinal fundus photographs collected from patients with mild cognitive impairment, Alzheimer’s disease, and vascular dementia. When deployed and commercialized, this system can assist in the identification of these biomarkers to aid in assessing drug/treatment efficacy and screening of the aging population in primary care practices and thus enable the early detection and effective management of patients with neurodegenerative disorders.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients older than 18 years and diagnosed with mild cognitive impairment (MCI), Alzheimer’s disease (AD), or vascular cognitive impairment and/or dementia (VaD).
Exclusion Criteria:
- Children and subjects with other diagnoses than those mentioned in the inclusion criteria.
- Patients without the means to visit the clinic on the assigned dates.
- Patients who are pregnant or are expecting to become pregnant.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Oana Dumitrascu, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available