BETTER Aging Trial: Brain Enhancement Training Towards Elders Resilience to Aging, Phase IIB
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 135
- 试验地点
- 2
- 主要终点
- Change in performance on global cognitive composite score
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The Investigators and Assessors will be blinded to the previous treatment assignment of participants from the Phase II study.
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Computerized Plasticity-Based Adaptive Cognitive Training (Other)
结局指标
主要结局
Change in performance on global cognitive composite score
时间窗: At 5 years and at 3 months
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.
次要结局
- 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)