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| Name | Class |
|---|---|
| University of Iowa | OTHER |
| The University of Texas at Dallas | OTHER |
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This study aims to examine the longer-term benefits of a novel, neuroplasticity-based, computerized and web-deliverable training program (PACR-CT) five years from the initial 10 weeks of training from our Phase II study - Protocol #: PSC-0605-17 (Aim 1) and test the interactive effect of previous training and 10 weeks of booster training (Aim 2). Both the study and the software being investigated meet the criteria of Non-Significant Risk.
This study will employ a single arm, open label design with use of the PACR-CT with all participants who completed the Phase II study, as well as approximately 60 new participants (with a goal of 40 completers) who are age-matched and untrained older adults. After consent, only the new, untrained participants will complete the screening visit. Then all participants will perform the pre-training visit (cognitive and functional assessments, MRI/fMRI and blood draw), followed by 10 weeks of training, and then followed by post-training visit (cognitive and functional assessments and MRI/fMRI).
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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. |
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| 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. |
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| 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 5 years and at 3 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 5 years and at 3 months |
| Change in performance on working 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 5 years and at 3 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 |
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The Investigators and Assessors will be blinded to the previous treatment assignment of participants from the Phase II study.
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Change in performance on working memory will be measured using the composite score created by averaging the z-scores of Visual Short Term Memory and N-Back Tasks. |
| At 5 years and at 3 months |
| Changes in performance on episodic memory | Change in performance on episodic memory will be measured using the composite score created by averaging the z-scores of Selective Reminding Task and Face Name Task. | At 5 years and at 3 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 and Task Switch (fMRI task). | At 5 years and at 3 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 5 years and 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 5 years and at 3 months |
| Change in task-related brain activation | Change in functional connectivity and brain activation will be measured while performing Task Switch. | At 5 years and 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 5 years and at 3 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 5 years and at 3 months |
| Blood-based Biomarker for Alzheimer's Disease | Group differences in the P-tau181, Aβ1-42/Aβ1-40 concentrations | At 5 years |
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 5 years and at 3 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 5 years and at 3 months |
| Change in Physical Activity | Change in total score based on weekly self-report dairy about physical activity during training period. | At 5 years and at 3 months |
| Change in Diet | Change in total score based on weekly self-report dairy about diet during training period. | At 5 years and at 3 months |
| Change in Social Activity | Change in total score based on weekly self-report dairy about social activity during training period. | At 5 years and at 3 months |
| Change in Sleep | Change in total score based on weekly self-report dairy about sleep during training period. | At 5 years and at 3 months |
| Change in Functional Abilities | Change in total score based on weekly self-report dairy about functional abilities during training period. | At 5 years and at 3 months |
| Dallas |
| Texas |
| 75235 |
| United States |