Brain Enhancement Training Towards Elders Resilience to Aging

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging)

Conditions
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Age-related Cognitive Decline

Intervention / Treatment
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* Other: Computerized Plasticity-Based Adaptive Cognitive Training
* Other: Commercially available computerized training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant must be 65 years of age or older Participant must be a fluent English speaker Participant must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse Participant must not have evidence of dementia as indicated by the Montreal Cognitive Assessment (MoCA) Exclusion Criteria: Participant with any medical illnesses, injuries or conditions predisposing to imminent functional and/or cognitive decline Participant requiring caregiver assistance in dressing/personal hygiene Participant with severe visual deficits (including visual neglect, partial field cuts, anopias) and/or severe hearing deficit that would prevent use of the computerized treatment program Participant with recent participation of computer-delivered cognitive training within 2 years of consent Participant with claustrophobia or any other contraindication to MRI scanning Participant with inability to complete a 1-hour MRI Pregnant women Participant with any implanted devices above the waist (e.g., cardiac pacemaker or auto-defibrillators, neural pacemaker, aneurysm clips, cochlear implant, metallic bodies in the eye or central nervous system, any form of wires or metal devices that may concentrate radio frequency fields) Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Treatment<br>Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session. | Other: Computerized Plasticity-Based Adaptive Cognitive Training<br>* Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.<br>|
| Active Comparator: Active Comparator<br>Commercially available computerized training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session. | Other: Commercially available computerized training<br>* Forty-two minutes of training on computerized, casual video games.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |