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

NCT ID: NCT04567745

Last Updated: 2021-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2021-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment Alzheimer Disease Vascular Dementia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cognitive diagnosis

Group Type OTHER

Retinal fundus photography

Intervention Type DIAGNOSTIC_TEST

Fundus photographs

Interventions

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Retinal fundus photography

Fundus photographs

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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).

* Patients without the means to visit the clinic on the assigned dates.
* Patients who are pregnant or are expecting to become pregnant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eyenuk, Inc.

INDUSTRY

Sponsor Role collaborator

Malavika Bhaskaranand PhD

UNKNOWN

Sponsor Role collaborator

Kaushal Solanki

UNKNOWN

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Oana M. Dumitrascu

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Oana Dumitrascu, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Arizona

Scottsdale, Arizona, United States

Site Status

Countries

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United States

Related Links

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https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

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20-007289

Identifier Type: -

Identifier Source: org_study_id