Clinical trial NCT04950673: Open-label, Post-marketing, Prospective Study to Assess Impact of COVID-19 on Cognitive Function in Patients
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cognitive Decline
Cognitive Dysfunction
Brain Health
Post CoV-2 Syndrome
COVID Long-Haul
Keywords: 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
Post CoV-2 Syndrome
COVID Long-Haul
Lead sponsor: Cognivue, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kaweah Delta District Hospital
name: Riiid Research LLC
name: UH, Cleveland Medical Center
name: US Medical Care INC
First posted: 2021-07-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1000 total subjects; 500 with COVID-19 history and 500 without COVID-19 diagnosis.

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.

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.

Eligibility 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

Primary outcomes:
measure: Cognitive decline
timeFrame: 24 months
Secondary outcomes:
measure: Comparison between Cognivue and other paper-pencil cognitive assessment batteries
timeFrame: 24 months
Other outcomes:
Locations:
city: Irvine
country: United States
facility: RiiiD Research, LLC
state: California
city: Visalia
country: United States
facility: Kaweah Health (Kaweah Delta District Hospital)
state: California
city: Boca Raton
country: United States
facility: US Medical Care Inc
state: Florida
city: Cleveland
country: United States
facility: UH Cleveland Medical Center
state: Ohio
Study officials:
affiliation: Cognivue, Inc.
name: Diego Cahn-Hidalgo, MD
role: PRINCIPAL_INVESTIGATOR
References: