Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04950673 |
| Other study ID # |
COG-COVID19 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 21, 2021 |
| Est. completion date |
April 30, 2024 |
Study information
| Verified date |
June 2022 |
| Source |
Cognivue, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
