NCT04567745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

September 29, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

Enrollment Period

1 year

First QC Date

September 23, 2020

Last Update Submit

October 28, 2021

Conditions

Mild Cognitive ImpairmentAlzheimer DiseaseVascular Dementia

Outcome Measures

Primary Outcomes (1)

  • retinopathy features identification

    The retinal vascular parameters computed using EyeQuant will be compared against the current gold-standard, based on expert annotations

    12 months

Study Arms (1)

Cognitive diagnosis

OTHER
Diagnostic Test: Retinal fundus photography

Interventions

Retinal fundus photographyDIAGNOSTIC_TEST

Fundus photographs

Cognitive diagnosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients older than 18 years and diagnosed with mild cognitive impairment (MCI), Alzheimer's disease (AD), or vascular cognitive impairment and/or dementia (VaD).

You may not qualify if:

  • Patients without the means to visit the clinic on the assigned dates.
  • Patients who are pregnant or are expecting to become pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer DiseaseDementia, Vascular

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Oana Dumitrascu, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 23, 2020

First Posted

September 28, 2020

Study Start

September 29, 2020

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

November 1, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)