BETTER Aging Trial: Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB
Overview
- Phase
- Not Applicable
- Intervention
- Computerized Plasticity-Based Adaptive Cognitive Training
- Conditions
- Age-related Cognitive Decline
- Sponsor
- Posit Science Corporation
- Enrollment
- 135
- Locations
- 2
- Primary Endpoint
- Change in performance on global cognitive composite score
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
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.
Detailed Description
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participant must be 70 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)
Arms & Interventions
Experimental Treatment
Computerized plasticity-based adaptive cognitive training requiring a total maximum of 50 treatment sessions, up to 5 sessions per week, 42 minutes per session.
Intervention: Computerized Plasticity-Based Adaptive Cognitive Training
Outcomes
Primary Outcomes
Change in performance on global cognitive composite score
Time Frame: At 5 years and at 3 months
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.
Secondary Outcomes
- Changes in performance on episodic memory(At 5 years and at 3 months)
- Blood-based Biomarker for Alzheimer's Disease(At 5 years)
- Change in brain function(At 5 years and at 3 months)
- Change in performance on processing speed composite score(At 5 years and at 3 months)
- Change in performance on working memory(At 5 years and at 3 months)
- Change in performance on executive function(At 5 years and at 3 months)
- Change in task-related brain activation(At 5 years and at 3 months)
- Change in brain structure(At 5 years and at 3 months)
- Change in functional performance(At 5 years and at 3 months)
- Change in Depressive Symptoms(At 5 years and at 3 months)