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NCT04567745 Clinical Trial

Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers

Alzheimer Disease Clinical Trial

Official title:
Clinical Validation of an Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Indicating Cognitive Decline

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04567745
Other study ID # 20-007289
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 29, 2020
Est. completion date September 30, 2021

Study information
Verified date October 2021
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Retinal fundus photography
Fundus photographs

Locations
Country Name City State
United States Mayo Clinic Arizona Scottsdale Arizona

Sponsors (4)
Lead Sponsor Collaborator
Mayo Clinic Eyenuk, Inc., Kaushal Solanki, Malavika Bhaskaranand PhD

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary retinopathy features identification The retinal vascular parameters computed using EyeQuant will be compared against the current gold-standard, based on expert annotations 12 months
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