Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:57 PM
Ignite Modification Date:
2025-12-24 @ 4:57 PM
NCT ID:
NCT07171450
Eligibility Criteria:
Inclusion Criteria:
* age ≥ 60 years old
* prior history of COVID-19 that was confirmed with viral testing (e.g., positive laboratory test or positive at-home rapid test)
* cognitive symptoms (e.g., memory or thinking concerns) following COVID- 19 infection that have lasted for at least 12 weeks and are still present
* clinically meaningfully subjective cognitive concerns (i.e., T-score \< 40) on the PROMIS-Cognitive Function Scale
* objective evidence of cognitive decline, as defined by performance on standardized measures of executive functioning, memory, or processing speed from the NIH Toolbox Cognition Battery that is at least 1 standard deviation below estimated premorbid cognitive functioning
* fluent in English language
* off psychiatric medication or on a stable dose for at least 8 weeks
Exclusion Criteria:
* history of neurological disorder with potential to interfere with study participation or confound results (e.g., uncontrolled seizure disorder, moderate to severe traumatic brain injury or stroke with persistent neurological deficits)
* history of dementia and/or dementia range performance on the Mini- Mental State Examination (i.e., score of less than or equal to 23)
* prior diagnosis of Mild Cognitive Impairment (MCI) or Mild Neurocognitive Disorder unrelated to the participant's history of COVID-19
* history of severe psychiatric illness that may interfere with study participation or confound results (e.g., bipolar disorder, schizophrenia, or other psychotic disorder)
* history of significant neurodevelopmental condition that may interfere with study participation or confound results (e.g., intellectual disability, autism spectrum disorder, or specific learning disorder with impairment in reading)
* alcohol or other substance use disorder within the past 2 years
* significant sensory impairments (e.g., blindness) that would interfere with the ability to complete neuropsychological measures or engage in the tablet-based intervention
* performance that is below expectation on a test of effort and validity
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT07171450
Study Brief:
Protocol Section:
NCT07171450