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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04567745
Recruitment Status : Completed
First Posted : September 28, 2020
Last Update Posted : November 1, 2021
Sponsor:
Collaborators:
Eyenuk, Inc.
Malavika Bhaskaranand PhD
Kaushal Solanki
Information provided by (Responsible Party):
Oana M. Dumitrascu, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer Disease Vascular Dementia Diagnostic Test: Retinal fundus photography Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Validation of an Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Indicating Cognitive Decline
Actual Study Start Date : September 29, 2020
Actual Primary Completion Date : September 30, 2021
Actual Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Cognitive diagnosis Diagnostic Test: Retinal fundus photography
Fundus photographs




Primary Outcome Measures :
  1. retinopathy features identification [ Time Frame: 12 months ]
    The retinal vascular parameters computed using EyeQuant will be compared against the current gold-standard, based on expert annotations



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04567745


Locations
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United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
Sponsors and Collaborators
Mayo Clinic
Eyenuk, Inc.
Malavika Bhaskaranand PhD
Kaushal Solanki
Investigators
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Principal Investigator: Oana Dumitrascu, MD Mayo Clinic
Additional Information:
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Responsible Party: Oana M. Dumitrascu, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT04567745    
Other Study ID Numbers: 20-007289
First Posted: September 28, 2020    Key Record Dates
Last Update Posted: November 1, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia, Vascular
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases