Brain Enhancement Training Towards Elders Resilience to Aging (BETTER Aging)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 4
- 主要终点
- Change in performance on global cognitive composite score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
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)
结局指标
主要结局
Change in performance on global cognitive composite score
时间窗: At 3 months and at 9 months
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.
次要结局
- Change in performance on memory(At 3 months and at 9 months)
- Change in task-related brain activation(At 3 months)
- Change in brain function(At 3 months)
- Change in functional performance(At 3 months and at 9 months)
- Change in Depressive Symptoms(At 3 months and at 9 months)
- Change in performance on processing speed composite score(At 3 months and at 9 months)
- Change in brain structure(At 3 months)
- Change in performance on executive function(At 3 months and at 9 months)