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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
135
Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.
University of Iowa
Iowa City, Iowa, United States
University of Texas at Dallas
Dallas, Texas, United States
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.
Time frame: At 5 years and at 3 months
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.
Time frame: At 5 years and at 3 months
Change in performance on working memory
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: At 5 years