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| Name | Class |
|---|---|
| University of Iowa | OTHER |
| The University of Texas at Dallas | OTHER |
| National Institute on Aging (NIA) | NIH |
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This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.
The primary objective of this study is to evaluate the effects of the experimental treatment (cognitive training) further outlined in this protocol on the cognitive abilities (e.g., processing speed, attention, working memory, and executive function), brain functionality, functional status and quality of life of individuals with age-related cognitive decline as compared to a computer-based active control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment | Experimental | Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session. |
|
| Active Comparator | Active Comparator | Commercially available computerized training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Plasticity-Based Adaptive Cognitive Training | Other | Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in performance on global cognitive composite score | Change in performance on global cognitive composite score based on the average of all normalized assessment measures. | At 3 months and at 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in performance on processing speed composite score | Change in performance on processing speed will be measured using the composite score created by averaging the z-scores of Pattern Comparison, Letter Comparison, and Digit Symbol Coding tasks. | At 3 months and at 9 months |
| Change in performance on memory |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stress | Between-group magnitude of change in sum score using the self-report measure, Perceived Stress Scale (PSS-10). The scoring range is 0-40. Higher scores indicate higher perceived stress. | At 3 months and at 9 months |
| Change in Self-Efficacy |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyun Kyu Lee, PhD | Posit Science Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States | ||
| University of Texas at Dallas |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38686621 | Derived | Lee HK, Basak C, Grant SJ, Ray NR, Skolasinska PA, Oehler C, Qin S, Sun A, Smith ET, Sherard GH, Rivera-Dompenciel A, Merzenich M, Voss MW. The Effects of Computerized Cognitive Training in Older Adults' Cognitive Performance and Biomarkers of Structural Brain Aging. J Gerontol B Psychol Sci Soc Sci. 2024 Jul 1;79(7):gbae075. doi: 10.1093/geronb/gbae075. |
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| Commercially available computerized training | Other | Forty-two minutes of training on computerized, casual video games. |
|
Change in performance on memory will be measured using the composite score created by averaging the z-scores of Selective Reminding Task, Face Name Task, and Visual Short Term Memory tasks. |
| At 3 months and at 9 months |
| Change in performance on executive function | Change in performance on executive function will be measured using the composite score created by averaging the z-scores of Flanker Task, N-Back Task and Task Switch (fMRI task). | At 3 months and at 9 months |
| Change in brain function | Change in resting state functional connectivity will be measured by resting State T2*weighted EPI-BOLD, a 10-minute task-free BOLD contrast sequence consisting of 300 volumes (TR=2000 ms/TE=30ms) at 3.4mm3 in-plane resolution and 3mm slice thickness. Participants will be instructed to keep their eyes open and maintain attention on a central gray fixation cross on a black screen. | At 3 months |
| Change in brain structure | 3D T1-Weighted multi-echo MPRAGE. Morphometric analyses will be based on this MRI sequence (not accelerated because the reliability of acceleration for multi-site studies has not yet been established). We will achieve spatial resolution of 1 x 1 x 1 mm voxels. | At 3 months |
| Change in task-related brain activation | Change in functional connectivity and brain activation will be measured while performing Task Switch. | At 3 months |
| Change in functional performance | Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance. | At 3 months and at 9 months |
| Change in Depressive Symptoms | Between-group magnitude of change in sum score using the self-report measure, Center for Epidemiologic Studies Depression Scale (CES-D). The scoring range is 0-60. Higher scores indicate the presence of more symptomatology. | At 3 months and at 9 months |
Between-group magnitude of change in sum score using the self-report measure, Self-Efficacy Survey. The scoring range is 10-40. Lower scores indicate lower self efficacy.
| At 3 months and at 9 months |
| Change in Life Satisfaction | Between-group magnitude of change in sum score using the self-report measure, Life Satisfaction Scale. The scoring range is 5-35. Lower scores indicate lower life satisfaction. | At 3 months and at 9 months |
| Change in Physical Activity | Change in total score based on weekly self-report dairy about physical activity during training period. | At 3 months |
| Change in Diet | Change in total score based on weekly self-report dairy about diet during training period. | At 3 months |
| Change in Social Activity | Change in total score based on weekly self-report dairy about social activity during training period. | At 3 months |
| Change in Sleep | Change in total score based on weekly self-report dairy about sleep during training period. | At 3 months |
| Change in Functional Abilities | Change in total score based on weekly self-report dairy about functional abilities during training period. | At 3 months |
| Dallas |
| Texas |
| 75235 |
| United States |