An interventional study of Computerized Plasticity-Based Adaptive Cognitive Training and Commercially available computerized training in Healthy Aging, sponsored by Posit Science Corporation. Completed at 1 site in Canada. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by Posit Science Corporation · Not applicable, Interventional, and Treatment
This study is a validation study to evaluate efficacy of a neuroplasticity-based, computerized cognitive training program INHANCE (Improving Neurological Health in Aging via Neuroplasticity-based Computerized Exercise) to improve neurological and neuropsychological health in older adults.
The primary objective of this study is to evaluate the impact of a targeted speed and alertness training program (INHANCE) to improve cognition in healthy older adults, as evidenced by standard measures of cognition, and positive improvements in the neuromodulatory cholinergic system as measured via positron-emission tomography (PET).
The investigators will employ a double-blind, parallel-arm, placebo-controlled, randomized clinical trial design comprised of a treatment group using INHANCE, a computerized program that trains speed of processing and attention, compared to an active control group using computer games in 92 healthy older adults.
Approximately 108 participants will be consented to ensure the successful completion of 92 participants (post 20% attrition). Participants will then complete the Screening (V0) assessments to determine eligibility. Following inclusion, participants will complete the Baseline (V1) assessments, PET imaging and structural MRI scan; participants will then be randomized into either the INHANCE training or Computer Games, and will engage in approximately 35 hours of program use for the 10-week intervention period. Approximately halfway through the intervention period (\~5 weeks), participants will complete Interim (V2) assessments to be compared to the Post-Intervention assessments. Following the 10-week intervention, participants will complete a Post-Intervention (V3) assessment and PET imaging to evaluate changes in cognitive function. Participants will then stop using their assigned program for 3 months and return for a Follow-up (V4) end-of-study assessment to evaluate the endurance of changes in cognitive function in the absence of further program use.
Posit Science Corporation is the lead sponsor of 36 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Other: Computerized Plasticity-Based Adaptive Cognitive Training
Commercially available computerized training requiring a total maximum of 70 treatment sessions, up to 7 sessions per week, 30 minutes per session.
Other: Commercially available computerized training
Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
Thirty minutes of training on computerized, casual video games.
Change Mean in FEOBV SUVR (Standardized Uptake Value Ratio) Through PET Imaging in the Anterior Cingulate Cortex
Change from baseline and 3 months (post-intervention) for the 18F-fluoroethoxybenzovesamicol (FEOBV) standardized uptake value ratio (SUVR) in the Anterior Cingulate Cortex as measured through Positron Emission Tomography (PET) ligand imaging. Higher score is better.
Time frame: At 3 months (post-intervention)
Change Mean in EXAMINER Executive Composite Score
The EXAMINER (Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research) is a computer-based battery of executive function tests yielding a single Executive Composite score across three subtests (Flanker, Anti-Saccades, Set-Shifting). The Executive Composite is a latent trait estimate using Empirical Bayes scoring from item-response theory and is therefore unitless and unbounded. For reference, validation studies report mean scores of 0.70 in healthy adults, 0.29 in patients with mild cognitive impairment, and -0.20 in patients with Alzheimer's disease. This outcome reports change in Executive Composite Score from baseline, calculated as the score at 3 months minus baseline and the score at 6 months minus baseline. Higher values indicate better executive functioning.
Time frame: At 3 months (post-intervention) and at 6 months (follow-up)
Change Mean Score in Useful Field of View (UFOV) Assessment
This is a computerized assessment that serves as a positive control for task learning. Raw scores are defined as the exposure duration at approximately 80% criterion accuracy in milliseconds accuracy in identification of central and peripheral targets. The best possible raw score is 32 milliseconds, and the worst possible score is 3162 milliseconds. Change was calculated as the score at 3 months minus the score at baseline, and as the score at 6 months minus the score at baseline. Lower values in milliseconds reflect better Useful Field of View performance.
Time frame: At 3 months (post-intervention) and at 6 months (follow-up)
Change Mean Target Frequency Level in Tonic and Phasic Alertness (TAPAT) Assessment
This is a computerized assessment that serves as a positive control for task learning. A single target frequency level required for users to achieve at least 80% accuracy in target and foil identification for a pre-specified target image presented among similar foil images. Target frequency level is recorded as an integer ranging from 1 to 7, where 1 corresponded to the easiest condition (40% target frequency among foils) and 7 represented the most challenging condition (10% target frequency among foils). Change was calculated as the score at 3 months minus the score at baseline, and as the score at 6 months minus the score at baseline. Higher scores indicate better performance.
Time frame: At 3 months (post-intervention) and at 6 months (follow-up)
| Milestone | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) |
|---|---|---|
| Started | 46 | 46 |
| Completed | 41 | 41 |
| Not completed | 5 | 5 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Withdrawal by subject | 4 | 4 |
| Withdrew: Lost to follow-up | 0 | 1 |
Change from baseline and 3 months (post-intervention) for the 18F-fluoroethoxybenzovesamicol (FEOBV) standardized uptake value ratio (SUVR) in the Anterior Cingulate Cortex as measured through Positron Emission Tomography (PET) ligand imaging. Higher score is better.
| Standard Uptake Value Ratio | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) |
|---|---|---|
| Change Mean in FEOBV SUVR (Standardized Uptake Value Ratio) Through PET Imaging in the Anterior Cingulate Cortex | 0.044 (0.006 to 0082) | 0.014 (-0.026 to 0.054) |
The EXAMINER (Executive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research) is a computer-based battery of executive function tests yielding a single Executive Composite score across three subtests (Flanker, Anti-Saccades, Set-Shifting). The Executive Composite is a latent trait estimate using Empirical Bayes scoring from item-response theory and is therefore unitless and unbounded. For reference, validation studies report mean scores of 0.70 in healthy adults, 0.29 in patients with mild cognitive impairment, and -0.20 in patients with Alzheimer's disease. This outcome reports change in Executive Composite Score from baseline, calculated as the score at 3 months minus baseline and the score at 6 months minus baseline. Higher values indicate better executive functioning.
| score on a scale | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) |
|---|---|---|
| At 3 months | 0.132 (-0.091 to 0.358) | 0.091 (-0.131 to 0.314) |
| At 6 months | 0.166 (-0.075 to 0.411) | 0.163 (-0.058 to 0.385) |
This is a computerized assessment that serves as a positive control for task learning. Raw scores are defined as the exposure duration at approximately 80% criterion accuracy in milliseconds accuracy in identification of central and peripheral targets. The best possible raw score is 32 milliseconds, and the worst possible score is 3162 milliseconds. Change was calculated as the score at 3 months minus the score at baseline, and as the score at 6 months minus the score at baseline. Lower values in milliseconds reflect better Useful Field of View performance.
| milliseconds | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) |
|---|---|---|
| At 3 months | 1.703 (1.390 to 2.021) | 0.174 (-0.166 to 0.512) |
| At 6 months | 1.666 (1.352 to 1.986) | 0.486 (0.245 to 0.726) |
This is a computerized assessment that serves as a positive control for task learning. A single target frequency level required for users to achieve at least 80% accuracy in target and foil identification for a pre-specified target image presented among similar foil images. Target frequency level is recorded as an integer ranging from 1 to 7, where 1 corresponded to the easiest condition (40% target frequency among foils) and 7 represented the most challenging condition (10% target frequency among foils). Change was calculated as the score at 3 months minus the score at baseline, and as the score at 6 months minus the score at baseline. Higher scores indicate better performance.
| Target frequency level | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) |
|---|---|---|
| At 3 months | 1.066 (0.763 to 1.363) | 0.171 (-0.140 to 0.481) |
| At 6 months | 1.179 (0.918 to 1.435) | 0.294 (-0.002 to 0.585) |
Collected over At 3 months (post-intervention) and at 6 months (follow-up). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Treatment (Speeded Training) | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Active Comparator (Non-Speeded Training) | 0/46 (0%) | 0/46 (0%) | 1/46 (2.2%) |
| Event | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) |
|---|---|---|
| mild dry mouthGastrointestinal disorders | 0/46 | 1/46 |
| mild strange sensation in the mouthGastrointestinal disorders | 0/46 | 1/46 |
| Age, Continuous(years) | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) | Total |
|---|---|---|---|
| Mean | 72.76 ± 5.25 | 71.04 ± 4.32 | 71.90 ± 4.85 |
| Sex: Female, Male(Participants) | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) | Total |
|---|---|---|---|
| Female | 29 | 32 | 61 |
| Male | 17 | 14 | 31 |
| Ethnicity (NIH/OMB)(Participants) | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 45 | 46 | 91 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Race (NIH/OMB)(Participants) | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 0 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 44 | 44 | 88 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Education(years) | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) | Total |
|---|---|---|---|
| Mean | 16.28 ± 3.53 | 16.63 ± 3.30 | 16.45 ± 3.40 |
| Native Language - English(participants) | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) | Total |
|---|---|---|---|
| Number | 17 | 16 | 33 |
| Montreal Cognitive Assessment (MoCA) Total Score(score on a scale) | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) | Total |
|---|---|---|---|
| Mean | 26.37 ± 1.83 | 25.98 ± 1.84 | 26.17 ± 1.83 |
| Geriatric Depression Scale - Short Form (GDS-SF) Total Score(score on a scale) | Experimental Treatment (Speeded Training) | Active Comparator (Non-Speeded Training) | Total |
|---|---|---|---|
| Mean | 1.24 ± 1.85 | 1.52 ± 1.91 | 1.38 ± 1.87 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jul 2021 to primary completion in Jun 2024, 34 months.
Results were first posted in Jul 2026, 2 years 1 month after primary completion.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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