Open-label, Post-marketing, Prospective Study to Assess Impact of COVID-19 on Cognitive Function in Patients
Status unconfirmed
Conditions studied: Cognitive Decline, Cognitive Dysfunction, Brain Health, Post CoV-2 Syndrome, COVID Long-Haul
In brief
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.
Key facts
- Study ID
- NCT04950673
- Run by
- Cognivue, Inc.
- People needed
- 1000
- Starts
- 2021-07-21
- Expected to finish
- 2024-04-30
- Last updated by the study team
- 2022-06-22
Who can join
Age: 18 and older, up to 95. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- RiiiD Research, LLC — Irvine, California, United States
- Kaweah Health (Kaweah Delta District Hospital) — Visalia, California, United States
- US Medical Care Inc — Boca Raton, Florida, United States
- UH Cleveland Medical Center — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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