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Open-label, Post-marketing, Prospective Study to Assess Impact of COVID-19 on Cognitive Function in Patients (COVID19)

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ClinicalTrials.gov Identifier: NCT04950673
Recruitment Status : Not yet recruiting
First Posted : July 6, 2021
Last Update Posted : July 6, 2021
Sponsor:
Collaborators:
University of Southern California
Case Western Reserve University
University of California, Irvine
Information provided by (Responsible Party):
Cognivue, Inc.

Brief Summary:
The objective of this study is to compare the impact of the coronavirus disease (SARS-CoV-2, or COVID-19) on cognitive function in the population of patients who have been diagnosed, treated and recovered from the COVID-19 infection versus patients who have not been infected. Primary endpoint is to evaluate the percentage of cognitive decline observed in both study arms (subjects with or without COVID-19 history) using assessments of Cognivue Clarity, MMSE and MoCA. Secondary endpoint is to see the correlation of Depression and anxiety scales (i.e., Patient Health Questionnaire-9 (PHQ-9) and/or Geriatric Depression Scale (GDS)) and Cognivue scores while comparing the trend of difference between both study arms.

Condition or disease Intervention/treatment Phase
Cognitive Decline Device: Cognivue Not Applicable

Detailed Description:

Cognivue is an FDA-cleared cognitive assessment device based on modern cognitive neuroscience, that allows physicians, allied healthcare providers, and patients to access a new approach to brain health, moving beyond the old questions and answers approach of traditional cognitive tests.

Cognivue's development and testing is based on 20 years of psychophysical and neurophysiological research that has focused on the early detection of patients' cognitive decline. Its FDA clearance study demonstrated significant correlation to the SLUMS and other neuropsychological tests, superior test re-test reliability compared to SLUMS, and validated its psychometric properties.

Historically, physicians have used the Mini-Mental Status Exam (MMSE) and Montreal Cognitive Assessment (MoCA) to assess cognitive functioning. These tools are often limited by issues of bias, inconsistent retest reliability, staffing and cost. The automated Cognivue technology utilizes adaptive psychophysics and assesses the patient's motor skills and visual acuity, eliminating the bias found in common cognitive testing mechanisms such as MMSE, MoCA, and Mini-Cog.

Using Cognivue Clarity, we have an opportunity to better understand a person in total when we insist that cognitive function testing is part of the recovery plan for individuals who experience the whiplash of COVID-19, either directly or indirectly.

This is a multi-site, open-label study. Approximately 1000 subjects will be enrolled. Up to 500 subjects with COVID-19 history and 500 subjects without a COVID-19 diagnosis will be enrolled in this study.

During the first visit, all subjects will be provided with an informed consent form (ICF) to review and sign prior to starting any study-specific procedures. Subjects will be asked about their COVID-19 diagnosis history, prior to study enrollment. After informed consent is obtained from subjects, study staff will review contact, demographic and medical history information. Following this review, cognitive testing using Cognivue Clarity, MMSE and MOCA will occur. In addition, subjects will take the Patient Health Questionnaire-9 (PHQ-9) and/or Geriatric Depression Scale (GDS) during this visit .

Subjects will be followed for 24 months in the study, coming to the study site to review COVID-19 infection (re-infection or newly diagnosed) as well as perform cognitive testing with Cognivue Clarity, MMSE and MOCA. Subjects will also take the PHQ-9 and/or GDS during these visits. In addition, during the 12- and 24-month visits, study staff will review previously reported medical history information with subjects to determine any new information.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study population consists of up to 1000 subjects who meet all inclusion criteria and none of the exclusion criteria. The study will enroll and compare 500 subjects with COVID-19 history and 500 subjects without a COVID-19 history of diagnosis.
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Open-label, Post-marketing, Prospective, Two-Armed Comparison Study to Assess Impact of SARS-CoV-2 or COVID-19 on Cognitive Function in Patients
Estimated Study Start Date : July 1, 2021
Estimated Primary Completion Date : November 30, 2023
Estimated Study Completion Date : April 30, 2024

Arm Intervention/treatment
Experimental: Subjects who had COVID-19 infection and recovered at 3 months
500 subjects who have had a history of COVID19 infection and recovered 3 months prior to the enrollment
Device: Cognivue
Computerized Cognitive Assessment Device

Experimental: Subjects who never had COVID-19 infection
500 subjects who never had a history of COVID19 infection prior to the enrollment
Device: Cognivue
Computerized Cognitive Assessment Device




Primary Outcome Measures :
  1. Cognitive decline [ Time Frame: 24 months ]
    The percentage of cognitive decline observed in both study arms (subjects with or without COVID-19 history) using assessments of Cognivue Clarity, Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA).


Secondary Outcome Measures :
  1. Comparison between Cognivue and other paper-pencil cognitive assessment batteries [ Time Frame: 24 months ]
    Depression and anxiety scales, i.e., Patient Health Questionnaire-9 (PHQ-9) or Geriatric Depression Scale (GDS).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   males and females
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 18 years old
  • Male or Female
  • Previous diagnosis of COVID-19, but recovered >3 months (Arm 1)
  • Never infected or diagnosed with COVID-19 (Arm 2)
  • Fluent in English
  • Able to operate simple computerized device
  • Willing to sign a written informed consent and ability to comply with study requirements
  • Ability to provide demographic and medical history information

Exclusion Criteria:

  • Individuals under 18 years old
  • Currently under COVID-19 treatment or quarantine
  • Previously known diagnosis of dementia and Alzheimer's
  • Inability to provide written informed consent for self or complete cognitive testing (either using Cognivue Clarity or paper/pencil testing)
  • Known severe terminal illness

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): NCT04950673


Contacts
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Contact: Hassan K Kassan, MS 6504523229 hhassan@cognivue.com
Contact: Fred Ma, MD, PhD 2164695725 fredma@cognivue.com

Locations
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United States, New York
Cognivue, Inc.
Victor, New York, United States, 14564
Contact: Hassan K Ma, MS    650-452-3229    hhassan@cognivue.com   
Contact: Fred Ma, MD, PhD    2164695725    fredma@cognivue.com   
Principal Investigator: Charles Liu, MD         
Sub-Investigator: Richard Pantera, MD         
Principal Investigator: Grace McComsey, MD         
Principal Investigator: Dung Trinh, MD         
Sub-Investigator: Grace Shin, PhD         
Principal Investigator: Brad Lipson, MD         
Sponsors and Collaborators
Cognivue, Inc.
University of Southern California
Case Western Reserve University
University of California, Irvine
Investigators
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Principal Investigator: Fred Ma, MD, PhD Cognivue, Inc.
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Responsible Party: Cognivue, Inc.
ClinicalTrials.gov Identifier: NCT04950673    
Other Study ID Numbers: COG-COVID19
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share participants' data with other researchers due to the HIPPA compliant issue

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Cognivue, Inc.:
SARS-CoV2
COVID19
Cognition
Cognivue
Institutional Review Board or IRB
Montreal Cognitive Assessment or MoCA
Mini-Mental Status Exam or MMSE
Patient Health Questionnaire or PHQ-9
Food Drug Administration or FDA
World Health Organization or WHO
Informed Consent Form or ICF
Case Report Form or CRF
Good Clinical Practice or GCP
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders