NCT07171450NARecruiting

Cognitive Remediation

Cutter Lindbergh

Start Date

1/21/2026

Completion Date

2/28/2030

Summary

The goal of this clinical trial is to determine if a neuroscience-based computerized cognitive remediation ("brain training") program can treat neurocognitive dysfunction (i.e., memory or thinking difficulties) that emerges in some older adults following a viral infection. The main questions it aims to answer are: * Does computerized cognitive remediation improve cognitive performance and day-to-day functioning in older adults with postviral neurocognitive dysfunction? * Will treatment effects be maintained over time, leading to better long term cognitive outcomes? * Does the treatment lead to reductions in blood-based markers of inflammation as a potential mechanism of cognitive symptom improvement? * Can the treatment be optimized and refined based on feedback from participants to improve user (patient) experience? Researchers will compare the computerized cognitive remediation program to an active computer-based control condition (alternative computer activities) to see if the computerized cognitive remediation program works to treat postviral neurocognitive dysfunction. Participation takes approximately 43-48 hours over 7 months, with most activities (40-46 hours) completed within the first 7-8 weeks, including: * Initial intake visit: Eligibility confirmation (\~2-3 hours) * Computer activities: About 5 hours per week for \~6 weeks (total \~30 hours) completed on a computer tablet provided by the study and loaned to participants for use during the treatment phase * Weekly remote check-in meetings: \~30 minutes each during treatment * Blood draws: Two sessions (before and after treatment), \~20-30 minutes each * Three research visits: Pre-treatment, post-treatment, and 6-month follow-up (\~2-3 hours each, including assessments of cognitive, emotional, and daily functioning)

Detailed Description

A significant minority of older adults display persistent cognitive impairments after the acute phase of a viral infection, referred to as Postviral Neurocognitive Dysfunction (PND). Underlying mechanisms remain poorly understood, though chronic neuroinflammation appears to reflect a key pathway. PND is debilitating, increases the risk for accelerated biological aging and dementia, and is associated with a substantial economic burden to society. Older adults are at heightened risk for PND given weakened immune systems, baseline age-related cognitive decline, and susceptibility to more severe acute viral illness. There is a critical lack of evidence-based treatments. The goal of this project is to determine the potential of a neuroplasticity-based computerized cognitive remediation (CCR) intervention for treating PND in older adults and probing underlying mechanisms. The proposed design is a randomized, two-arm, clinical trial pilot study. Older adults with PND (N = 75) will be assigned to a 6-week course of neuroplasticity-based CCR or an active, computer-based control condition. Specific aims are to: examine preliminary efficacy of CCR for improving cognitive performance and day-to-day functioning in older adults with PND (Aim 1); optimize and refine the CCR program for older adults with PND using iterative, data-driven, participatory design methodology (Aim 2); and determine if CCR reduces peripheral inflammation as a potential mechanism of clinical symptom relief (Exploratory Aim 3).

Eligibility Criteria

Age Range: 60 years to No maximum

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 \[\*at least one third of the sample, or 25 out of 75 subjects, will be required to meet this inclusion criterion\] * 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

Interventions

OTHER

Computerized Cognitive Remediation

OTHER

Alternative Computer Activities

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Conditions

AgingInflammationCognitive RemediationCognitive DysfunctionPostviral SyndromeDigital Medicine

Locations

UConn Health

Farmington, Connecticut 06030

United States