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
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Decline||Device: Cognivue||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1000 participants|
|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)|
|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|
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
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
Computerized Cognitive Assessment Device
- 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).
- 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).
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
|Contact: Hassan K Kassan, MSfirstname.lastname@example.org|
|Contact: Fred Ma, MD, PhDemail@example.com|
|United States, New York|
|Victor, New York, United States, 14564|
|Contact: Hassan K Ma, MS 650-452-3229 firstname.lastname@example.org|
|Contact: Fred Ma, MD, PhD 2164695725 email@example.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|
|Principal Investigator:||Fred Ma, MD, PhD||Cognivue, Inc.|