Cognitive DeclineCOVID19NCT04950673
Open-label, Post-marketing, Prospective Study to Assess Impact of COVID-19 on Cognitive Function in Patients
An observational study of Cognitive Decline and Cognitive Dysfunction, run by Cognivue, Inc. at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Decline, Cognitive Dysfunction, Brain Health
- What is being tested?
- Cognivue
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 4 sitesUnited States
- Study dates
- 21 Jul 2021to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 1000 total subjects; 500 with COVID-19 history and 500 without COVID-19 diagnosis.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
US Medical Care Inc
Boca Raton, Florida, 33431
UH Cleveland Medical Center
Cleveland, Ohio, 44106
RiiiD Research, LLC
Irvine, California, 92618
Kaweah Health (Kaweah Delta District Hospital)
Visalia, California, 93291
About this study
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
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.
Read the 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.
- Conditions
- Cognitive Decline, Cognitive Dysfunction, Brain Health, Post CoV-2 Syndrome, COVID Long-Haul
- Being tested
- Cognivue
- 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
- Medical subject headings
- Cognitive Dysfunction, Post-Acute COVID-19 Syndrome, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CognivueDevice
Computerized Cognitive Assessment Device
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Cognivue | |
| Subjects who never had COVID-19 infection | 500 subjects who never had a history of COVID19 infection prior to the enrollment Receives: Device: Cognivue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive decline
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).
Measured: 24 months
Secondary outcomes (1)
Comparison between Cognivue and other paper-pencil cognitive assessment batteries
Depression and anxiety scales, i.e., Patient Health Questionnaire-9 (PHQ-9) or Geriatric Depression Scale (GDS).
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start21 Jul 2021
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cognivue, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaweah Delta District Hospital, Riiid Research LLC, UH, Cleveland Medical Center, US Medical Care INC
- Responsible party
- Sponsor
- Investigators
- Diego Cahn-Hidalgo, MD, Principal investigator, Cognivue, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950673
- Sponsor's protocol ID
- COG-COVID19
- Acronym
- COVID19
- Status last verified
- Jun 2022
- First submitted
- 30 Jun 2021
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan to share participants' data with other researchers due to the HIPAA compliant issue
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04950673
- Acronym / sponsor ID
- COVID19 / COG-COVID19
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Cognivue, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Kaweah Delta District Hospital, Riiid Research LLC, UH, Cleveland Medical Center, US Medical Care INC
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects who had COVID-19 infection and recovered at 3 months | – | Device: Cognivue500 subjects who have had a history of COVID19 infection and recovered 3 months prior to the enrollment |
| Subjects who never had COVID-19 infection | – | Device: Cognivue500 subjects who never had a history of COVID19 infection prior to the enrollment |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1000 total subjects; 500 with COVID-19 history and 500 without COVID-19 diagnosis.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CognivueComputerized Cognitive Assessment Device | Device | Subjects who had COVID-19 infection and recovered at 3 months, Subjects who never had COVID-19 infection |
Primary outcome
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).
1 secondary outcome
Comparison between Cognivue and other paper-pencil cognitive assessment batteries
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Individual participant dataSharing planned: No. No plan to share participants' data with other researchers due to the HIPAA compliant issue
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego Cahn-Hidalgo, MD principal investigator
Cognivue, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Decline and Cognitive Dysfunction, run by Cognivue, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive decline (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.