AgingNCT07171450
Cognitive Remediation
A study testing Computerized Cognitive Remediation and Alternative Computer Activities in people with Aging and Inflammation, run by Cutter Lindbergh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging, Inflammation, Cognitive Remediation
- What is being tested?
- Computerized Cognitive Remediation and Alternative Computer Activities
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2026to 28 Feb 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UConn Health
Farmington, Connecticut, 06030
About this study
Official title: Computerized Cognitive Remediation of Postviral Neurocognitive Dysfunction in Older Adults
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.
Read more
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)
Read the 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).
- Conditions
- Aging, Inflammation, Cognitive Remediation, Cognitive Dysfunction, Postviral Syndrome, Digital Medicine
- Being tested
- Computerized Cognitive Remediation, Alternative Computer Activities
- Keywords
- Aging, Inflammation, Cognitive Remediation, Cognitive dysfunction, Postviral Syndrome, digital medicine
- Medical subject headings
- Inflammation, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive RemediationOther
Also called NeuroFlex
The computerized cognitive remediation intervention ("NeuroFlex") consists of a series of gamified tasks administered via computer tablet. The intervention provides both "bottom up" training to improve basic processing of sensory stimuli and "top down" training to improve executive functions. Importantly, NeuroFlex personalizes gameplay with adaptive algorithms that adjust difficulty on a trial-by-trial basis. Participants are prescribed a 30-hour dose distributed across 6 weeks. The treatment is completed remotely by the participant within their own home or other private location that is most convenient for the participant.
Alternative Computer ActivitiesOther
The active control condition is carefully matched to the experimental condition in duration, computer tablet use, audiovisual stimulation, reward presentation, and interaction with study staff. It involves playing visuospatially-oriented computerized games that do not load on executive functions and watching stimulating educational videos.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Cognitive Remediation | Experimental | Not described Receives: Other: Computerized Cognitive Remediation |
| Active Computer-Based Control | Active comparator | Not described Receives: Other: Alternative Computer Activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group Difference in Set-Shifting Abilities at Post-Treatment as Measured with Trails B
Part B of the Trail Making Test (Trails B) is an executive functioning measure of set-shifting abilities in which the examinee must rapidly alternate between connecting numbers and letters distributed across a page. The total time (in seconds) required for the examinee to complete the task is recorded. Lower scores (in seconds) indicate better performance. Time to complete Trails B at the post-treatment visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment Trails B performance.
Measured: Pre-treatment and post-treatment (Week 7)
Group Difference in Set-Shifting Abilities at 6 Months as Measured with Trails B
Part B of the Trail Making Test (Trails B) is an executive functioning measure of set-shifting abilities in which the examinee must rapidly alternate between connecting numbers and letters distributed across a page. The total time (in seconds) required for the examinee to complete the task is recorded. Lower scores (in seconds) indicate better performance. Time to complete Trails B at the 6-month visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment Trails B performance.
Measured: Pre-treatment and 6 Months
User Experience/Interface with Computerized Cognitive Remediation Program at Post-Treatment as Measured with the System Usability Scale
The System Usability Scale is a well-validated, 10-item, self-report questionnaire of user experience/interface (UX/ UI) with computer-based programs. Participants rate each item using a 5-point Likert-style scale with response options ranging from "Strongly Disagree" to "Strongly Agree". Total scores ranging from 0-100 are calculated using a standard equation. Higher total scores indicate better UX/UI.
Measured: Post-Treatment (Week 7)
Secondary outcomes (12)
Group Difference in Inhibitory Control at Post-Treatment as Measured with the Stroop Color and Word Test
The Stroop Color and Word Test is an executive functioning measure of inhibitory control in which the examinee is presented with a sheet containing words of various colors printed in discordant ink colorings. The examinee is instructed to rapidly name the color of the ink that the words are printed in without reading the printed word (i.e., the prepotent response must be inhibited). An interference score is calculated by determining how many items the examinee completes within a set period of time, subtracting out their performance on baseline conditions (without an interference component) to control for processing speed. Higher scores indicate better performance. The score at the post-treatment visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Measured: Pre-treatment and post-treatment (Week 7)
Group Difference in Inhibitory Control at 6 Months as Measured with the Stroop Color and Word Test
The Stroop Color and Word Test is an executive functioning measure of inhibitory control in which the examinee is presented with a sheet containing words of various colors printed in discordant ink colorings. The examinee is instructed to rapidly name the color of the ink that the words are printed in without reading the printed word (i.e., the prepotent response must be inhibited). An interference score is calculated by determining how many items the examinee completes within a set period of time, subtracting out their performance on baseline conditions (without an interference component) to control for processing speed. Higher scores indicate better performance. The score at the 6-Month visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Measured: Pre-treatment and 6 months
Group Difference in Verbal Generativity, Initiation, and Strategy Use at Post-Treatment as Measured with the Controlled Oral Word Association Test (COWAT)
The COWAT is an executive functioning measure of verbal generativity, initiation, and strategy use in which the examinee must quickly generate as many words as possible, within a set period of time, according to pre-specified rules (e.g., words starting with a certain letter of the alphabet). A total score is calculated by adding up the number of words that were correctly produced within the time limit. Higher total scores indicate better performance. The score at the post-treatment visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Measured: Pre-treatment and post-treatment (Week 7)
Group Difference in Verbal Generativity, Initiation, and Strategy Use at 6 Months as Measured with the Controlled Oral Word Association Test (COWAT)
The COWAT is an executive functioning measure of verbal generativity, initiation, and strategy use in which the examinee must quickly generate as many words as possible, within a set period of time, according to pre-specified rules (e.g., words starting with a certain letter of the alphabet). A total score is calculated by adding up the number of words that were correctly produced within the time limit. Higher total scores indicate better performance. The score at the 6-month visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Measured: Pre-treatment and 6-months
Group Difference in Attention-Related Problems at Post-Treatment as Measured with the Conners Continuous Performance Test
The Conners Continuous Performance Test (Conners CPT) is a computerized measure of attention-related problems in which isolated letters are flashed briefly on a computer screen. The examinee is instructed to respond (by keypress) as quickly as possible whenever any letter appears on the screen, except for when the non-target letter appears. A summary measure of attention can be calculated based on the examinee's performance over the course of the test. The score at the post-treatment visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Measured: Pre-treatment and post-treatment (Week 7)
Group Difference in Attention-Related Problems at 6 Months as Measured with the Conners Continuous Performance Test
The Conners Continuous Performance Test (Conners CPT) is a computerized measure of attention-related problems in which isolated letters are flashed briefly on a computer screen. The examinee is instructed to respond (by keypress) as quickly as possible whenever any letter appears on the screen, except for when the non-target letter appears. A summary measure of attention can be calculated based on the examinee's performance over the course of the test. The score at the 6-month visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Measured: Pre-treatment and 6-months
Group Difference in Subjective Cognitive Concerns at Post-Treatment as Measured with the Everyday Cognition Scale (ECog)
The ECog is a self-report questionnaire of subjective cognitive concerns covering various domains, including memory, language, visuospatial skills, planning, organization, and divided attention. It uses a Likert-style scale ranging from 1-4, where 1 is "better or no change" and 4 is "consistently much worse" compared to prior. A total score, the average of all completed items ranging from 1 to 4, can be calculated to provide a global index of subjective cognitive concerns across domains. Lower total scores indicate better everyday cognitive functioning. The score at the post-treatment visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Measured: Pre-treatment and post-treatment (Week 7)
Group Difference in Subjective Cognitive Concerns at 6 Months as Measured with the Everyday Cognition Scale (ECog)
The ECog is a self-report questionnaire of subjective cognitive concerns covering various domains, including memory, language, visuospatial skills, planning, organization, and divided attention. It uses a Likert-style scale ranging from 1-4, where 1 is "better or no change" and 4 is "consistently much worse" compared to prior. A total score, the average of all completed items ranging from 1 to 4, can be calculated to provide a global index of subjective cognitive concerns across domains. Lower total scores indicate better everyday cognitive functioning. The score at the 6-month visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Measured: Pre-treatment and 6-months
Group Difference in Functional Disability at Post-Treatment as Measured with the World Health Organization Disability Assessment Schedule (WHODAS)
The WHODAS is a 36-item assessment instrument that measures functional disability in multiple domains, including cognition, mobility, selfcare, getting along (i.e., interacting with others), life activities, and participation (e.g., joining in community and societal activities). A summary score, ranging from 0 to 100, can be calculated that provides a measure of overall functioning across domains. Higher summary scores correspond to greater levels of functional disability. The score at the post-treatment visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Measured: Pre-treatment and post-treatment (Week 7)
Group Difference in Functional Disability at 6 Months as Measured with the World Health Organization Disability Assessment Schedule (WHODAS)
The WHODAS is a 36-item assessment instrument that measures functional disability in multiple domains, including cognition, mobility, selfcare, getting along (i.e., interacting with others), life activities, and participation (e.g., joining in community and societal activities). A summary score, ranging from 0 to 100, can be calculated that provides a measure of overall functioning across domains. Higher summary scores correspond to greater levels of functional disability. The score at the 6-month visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Measured: Pre-treatment and 6-months
Group Difference in Episodic Memory at Post-Treatment as Measured with the California Verbal Learning Test (CVLT)
The CVLT is a test of episodic memory that assesses the examinee's ability to learn and recall a list of words. The number of words correctly recalled after a delay period is measured (Long Delay Free Recall). Higher scores (i.e., more words recalled) correspond to better memory performance. The score at the post-treatment visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Measured: Pre-treatment and post-treatment (Week 7)
Group Difference in Episodic Memory at 6 Months as Measured with the California Verbal Learning Test (CVLT)
The CVLT is a test of episodic memory that assesses the examinee's ability to learn and recall a list of words. The number of words correctly recalled after a delay period is measured (Long Delay Free Recall). Higher scores (i.e., more words recalled) correspond to better memory performance. The score at the 6-month visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment performance.
Measured: Pre-treatment and 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start21 Jan 2026
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized two-arm, pre-post, clinical trial pilot study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cutter Lindbergh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Cutter Lindbergh, UConn Health
- Investigators
- Cutter Lindbergh, Ph.D., Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171450
- Sponsor's protocol ID
- 25-389-2
- Other IDs
- 1K23AG086612-01A1
- Status last verified
- Feb 2026
- First submitted
- 5 Sep 2025
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from this project will be shared to enable analysis of the research findings described in the project aims. This includes individual subject level data on cognitive functioning, everyday functioning, cytokine concentrations, measures of intervention user experience, and pertinent demographics.
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Remediation of Postviral Neurocognitive Dysfunction in Older Adults
- ClinicalTrials.gov ID
- NCT07171450
- Acronym / sponsor ID
- 25-389-2
- Conditions
- Aging, Inflammation, Cognitive Remediation, Cognitive Dysfunction, Postviral Syndrome, Digital Medicine
- Keywords
- Aging, Inflammation, Cognitive Remediation, Cognitive dysfunction, Postviral Syndrome, digital medicine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cutter LindberghUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 21 Jan 2026 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 12 Sep 2025 (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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a randomized two-arm, pre-post, clinical trial pilot study.
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Remediation | Experimental | Other: Computerized Cognitive Remediation |
| Active Computer-Based Control | Active comparator | Other: Alternative Computer Activities |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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]
Key exclusion criteria (8 listed)
- 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)
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 |
|---|---|---|
| Computerized Cognitive RemediationAlso: NeuroFlexThe computerized cognitive remediation intervention ("NeuroFlex") consists of a series of gamified tasks administered via computer tablet. The intervention provides both "bottom up" training to improve basic processing of sensory stimuli and "top down" training to improve executive functions. Importantly, NeuroFlex personalizes gameplay with adaptive algorithms that adjust difficulty on a trial-by-trial basis. Participants are prescribed a 30-hour dose distributed across 6 weeks. The treatment is completed remotely by the participant within their own home or other private location that is most convenient for the participant. | Other | Computerized Cognitive Remediation |
| Alternative Computer ActivitiesThe active control condition is carefully matched to the experimental condition in duration, computer tablet use, audiovisual stimulation, reward presentation, and interaction with study staff. It involves playing visuospatially-oriented computerized games that do not load on executive functions and watching stimulating educational videos. | Other | Active Computer-Based Control |
Primary outcome
Group Difference in Set-Shifting Abilities at Post-Treatment as Measured with Trails B
Time frame: Pre-treatment and post-treatment (Week 7)
Part B of the Trail Making Test (Trails B) is an executive functioning measure of set-shifting abilities in which the examinee must rapidly alternate between connecting numbers and letters distributed across a page. The total time (in seconds) required for the examinee to complete the task is recorded. Lower scores (in seconds) indicate better performance. Time to complete Trails B at the post-treatment visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment Trails B performance.
Group Difference in Set-Shifting Abilities at 6 Months as Measured with Trails B
Time frame: Pre-treatment and 6 Months
Part B of the Trail Making Test (Trails B) is an executive functioning measure of set-shifting abilities in which the examinee must rapidly alternate between connecting numbers and letters distributed across a page. The total time (in seconds) required for the examinee to complete the task is recorded. Lower scores (in seconds) indicate better performance. Time to complete Trails B at the 6-month visit will be compared between treatment groups (i.e., NeuroFlex vs. Active Control Condition), controlling for pre-treatment Trails B performance.
User Experience/Interface with Computerized Cognitive Remediation Program at Post-Treatment as Measured with the System Usability Scale
Time frame: Post-Treatment (Week 7)
The System Usability Scale is a well-validated, 10-item, self-report questionnaire of user experience/interface (UX/ UI) with computer-based programs. Participants rate each item using a 5-point Likert-style scale with response options ranging from "Strongly Disagree" to "Strongly Agree". Total scores ranging from 0-100 are calculated using a standard equation. Higher total scores indicate better UX/UI.
12 secondary outcomes
Group Difference in Inhibitory Control at Post-Treatment as Measured with the Stroop Color and Word Test
Time frame: Pre-treatment and post-treatment (Week 7)
Group Difference in Inhibitory Control at 6 Months as Measured with the Stroop Color and Word Test
Time frame: Pre-treatment and 6 months
Group Difference in Verbal Generativity, Initiation, and Strategy Use at Post-Treatment as Measured with the Controlled Oral Word Association Test (COWAT)
Time frame: Pre-treatment and post-treatment (Week 7)
Group Difference in Verbal Generativity, Initiation, and Strategy Use at 6 Months as Measured with the Controlled Oral Word Association Test (COWAT)
Time frame: Pre-treatment and 6-months
Group Difference in Attention-Related Problems at Post-Treatment as Measured with the Conners Continuous Performance Test
Time frame: Pre-treatment and post-treatment (Week 7)
Group Difference in Attention-Related Problems at 6 Months as Measured with the Conners Continuous Performance Test
Time frame: Pre-treatment and 6-months
Group Difference in Subjective Cognitive Concerns at Post-Treatment as Measured with the Everyday Cognition Scale (ECog)
Time frame: Pre-treatment and post-treatment (Week 7)
Group Difference in Subjective Cognitive Concerns at 6 Months as Measured with the Everyday Cognition Scale (ECog)
Time frame: Pre-treatment and 6-months
Group Difference in Functional Disability at Post-Treatment as Measured with the World Health Organization Disability Assessment Schedule (WHODAS)
Time frame: Pre-treatment and post-treatment (Week 7)
Group Difference in Functional Disability at 6 Months as Measured with the World Health Organization Disability Assessment Schedule (WHODAS)
Time frame: Pre-treatment and 6-months
Group Difference in Episodic Memory at Post-Treatment as Measured with the California Verbal Learning Test (CVLT)
Time frame: Pre-treatment and post-treatment (Week 7)
Group Difference in Episodic Memory at 6 Months as Measured with the California Verbal Learning Test (CVLT)
Time frame: Pre-treatment and 6-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: Yes. Data from this project will be shared to enable analysis of the research findings described in the project aims. This includes individual subject level data on cognitive functioning, everyday functioning, cytokine concentrations, measures of intervention user experience, and pertinent demographics.
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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.
Cutter Lindbergh, Ph.D. principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Remediation and Alternative Computer Activities in people with Aging and Inflammation, run by Cutter Lindbergh at 1 site 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Holly Eddy, Ph.D., LMFT-S (860-679-3751, eddy@uchc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group Difference in Set-Shifting Abilities at Post-Treatment as Measured with Trails B (time frame: Pre-treatment and post-treatment (Week 7)). The study lists 3 primary outcomes in all. 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 24 Feb 2026.