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

Mayo Clinic

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease; Mild Cognitive Impairment; Vascular Dementia

Treatments: Diagnostic Test: Retinal fundus photography

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04567745

20-007289

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Cognitive diagnosis

Other group

Treatment:

Diagnostic Test: Retinal fundus photography