Automated Retinal Image Analysis System (EyeQuant) for Co... | NCT04567745

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

NCT04567745

Sponsor

Mayo Clinic

Status

Completed

Last Update Posted

Nov 1, 2021Actual

Enrollment

80Actual

Phase

Phase 1

Conditions

Mild Cognitive Impairment
Alzheimer Disease
Vascular Dementia

Interventions

Retinal fundus photography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2020Actual

Primary Completion Date

Sep 30, 2021Actual

Completion Date

Sep 30, 2021Actual

First Submitted Date

Sep 23, 2020

First Submission Date that Met QC Criteria

Sep 23, 2020

First Posted Date

Sep 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2021

Last Update Posted Date

Nov 1, 2021Actual

Name	Class
Eyenuk, Inc.	INDUSTRY
Malavika Bhaskaranand PhD	UNKNOWN
Kaushal Solanki	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cognitive diagnosis	Other		Diagnostic Test: Retinal fundus photography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Retinal fundus photography	Diagnostic Test	Fundus photographs	Cognitive diagnosis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Oana Dumitrascu, MD	Mayo Clinic	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mayo Clinic Arizona		Scottsdale	Arizona	85259	United States

Label	URL
Mayo Clinic Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D060825	Cognitive Dysfunction
D000544	Alzheimer Disease
D015140	Dementia, Vascular

Ancestor Terms

ID	Term
D003072	Cognition Disorders
D019965	Neurocognitive Disorders
D001523	Mental Disorders
D003704	Dementia

Browse Leaves

Not provided

Browse Branches

Not provided