Back to resultsAutomated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers
Primary Purpose
Mild Cognitive Impairment, Alzheimer Disease, Vascular Dementia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Retinal fundus photography
Sponsored by
About this trial
This is an interventional diagnostic trial for Mild Cognitive Impairment
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.
Sites / Locations
- Mayo Clinic Arizona
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Cognitive diagnosis
Arm Description
Outcomes
Primary Outcome Measures
retinopathy features identification
The retinal vascular parameters computed using EyeQuant will be compared against the current gold-standard, based on expert annotations
Secondary Outcome Measures
Full Information
NCT ID
NCT04567745
First Posted
September 23, 2020
Last Updated
October 28, 2021
Sponsor
Mayo Clinic
Collaborators
Eyenuk, Inc., Malavika Bhaskaranand PhD, Kaushal Solanki
1. Study Identification
Unique Protocol Identification Number
NCT04567745
Brief Title
Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers
Official Title
Clinical Validation of an Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Indicating Cognitive Decline
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
September 29, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Eyenuk, Inc., Malavika Bhaskaranand PhD, Kaushal Solanki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer Disease, Vascular Dementia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cognitive diagnosis
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Retinal fundus photography
Intervention Description
Fundus photographs
Primary Outcome Measure Information:
Title
retinopathy features identification
Description
The retinal vascular parameters computed using EyeQuant will be compared against the current gold-standard, based on expert annotations
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oana Dumitrascu, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers
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