Plasticity-based Adaptive Cognitive Remediation for Alzheimer Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Changes in performance on global cognitive composite score
研究概览
简要总结
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.
详细描述
The normal aging has a devastating effect on our cognitive ability to learn and remember, on the speed with which the investigators process information, and on our ability to reason. By 2050, nearly 14 million individuals in the US will be living with Alzheimer's disease (AD), up from 5 million in 2013. AD is the most common cause of dementia, resulting in the loss of cognitive functions such as memory, reasoning, language, and cognitive, social, physical, and emotional control, to the extent that losses interfere with activities of daily living and necessitate continuous monitoring and care. Many studies now show that the processing machinery of the brain is plastic and remodeled throughout life by learning and experience, enabling the strengthening of cognitive skills or abilities. Research has shown that brief, daily computerized cognitive training that is sufficiently challenging, goal-directed and adaptive enables intact brain structures to restore balance in attention and compensate for disruptions in cognitive functioning. The study aims to understand how our computer program can affect cognition and attention in those with aging brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 79 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65-79 years at the time of consent
- •Fluent English speakers, to ensure reasonable results neuropsychological assessments
- •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
- •No evidence of dementia as indicated by Montreal Cognitive Assessment (MoCA) scores >25
排除标准
- •Diagnosis with Alzheimer's disease or related dementias
- •Requiring caregiver assistance in dressing/personal hygiene
- •Medical conditions predisposing to imminent functional decline
- •Recent participation of computer-delivered cognitive training
- •Diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis) will be excluded due to the confound with cognitive impairment from normal aging.
- •Uncorrectable acuity greater than 20/40
- •Self-reported cardiovascular disease
- •Claustrophobia or any other contraindication to MRI scanning
- •Inability to complete a 1-hour MRI
- •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)
- •History of brain surgery; removal of brain tissue; or history of stroke.
研究组 & 干预措施
Computerized Plasticity-based Software
Computerized Plasticity-based software training requiring a total maximum of 50 treatment sessions, 4-5 times weekly, 40 minutes each session.
干预措施: Computerized Plasticity-based Software (Behavioral)
Commercially available video game
Commercially available video game training. Treatment is software based, will occur up to 50 times throughout study duration, 4-5 times per week, 40 minutes each session..
干预措施: Commercially available Video Game (Behavioral)
结局指标
主要结局
Changes in performance on global cognitive composite score
时间窗: Baseline and at the completion of 10 weeks of training
Change in performance on global cognitive composite score based on the average of all normalized assessment measures.
次要结局
- Changes in brain function(Baseline and at the completion of 10 weeks of training)
- Changes in brain structure(Baseline and at the completion of 10 weeks of training)
- Changes in task-related brain activation(Baseline and at the completion of 10 weeks of training)
- Changes in performance on memory composite score(Baseline and at the completion of 10 weeks of training)
- Changes in performance on executive function composite score(Baseline and at the completion of 10 weeks of training)
- Changes in performance on processing speed composite score(Baseline and at the completion of 10 weeks of training)