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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
147
Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.
Forty-two minutes of training on computerized, casual video games.
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 3 months and at 9 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 3 months and at 9 months
Change in performance on memory
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
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Time frame: 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 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 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.
Time frame: At 3 months and at 9 months