The CTA-MCI Study: a Randomized Controlled Clinical Trial to Evaluate the Effect of Cognitive Control Training on Episodic Memory Function in Patients With Amnestic Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
This study evaluates the efficacy and mechanism of internet-based cognitive control training on episodic memory function in patients with amnestic Mild Cognitive Impairment(aMCI). Half of participants will receive adaptive internet-based cognitive control training program, while the other half will receive a fixed, primary difficulty level task.
详细描述
Background:
Alzheimer's disease (AD) is a common dementia in elderly populations, and amnestic mild cognitive impairment (aMCI) refers to a transitional stage between normal aging and early dementia. Patients with aMCI are at higher risks of evolving toward AD. Although it has been widely recognized that early intervention of aMCI holds the potential to delay or even reverse the cognitive impairment, no treatment is available yet. Episodic memory dysfunction is the characteristic impairment in aMCI, cognitive control training significantly improved executive function in patients with aMCI . Whether and how cognitive control training improves episodic memory function in patients with aMCI remains largely unknown.
Objectives:
The primary objective of this double-blinded, randomized RCT is to assess whether internet-based cognitive control training in patients with amnestic Mild Cognitive Impairment improves their episodic memory function. The second objective is to evaluate the effect of cognitive control training on neural plasticity, including brain activation and white matter integrity, which are assessed by functional and structural MRI.
Patients and Methods:
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Literate Chinese, aged 50 years and older
- •Complaint about memory loss and confirmed by an informant
- •Cognitive impairment in memory domain, adjusted for age and education
- •Normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities
- •Clinical dementia rating (CDR) =0.5, Mini-Mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above)
- •Failure to meet the criteria for dementia
排除标准
- •history of clinically significant stroke
- •neurological diseases that may lead to neurological distortion, including schizophrenia, severe anxiety or depression, frontotemporal dementia，Huntington disease, brain tumor, parking disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal pressure hydrocephalus
- •systemic diseases that may lead to neurological distortion, including hypothyroidism, folic acid deficiency, vitamin B12 deficiency, severe anemia, specific infection such as HIV and syphilis
- •clinically significant gastrointestinal, renal, hepatic, respiratory, endocrine, or cardiovascular system disease;
- •cancer, alcoholism, drug addiction;
- •severe aphasia, physical disabilities, or any other factor that may preclude completion of neuropsychological testing;
- •use of medications that may affect cognitive functioning, including tranquilizers, anti-anxiolytics, hypnotics, nootropics, and cholinomimetic agents;
- •inability to undergo a brain MRI.
研究组 & 干预措施
training group
Intervention: Internet-based adaptive cognitive control training program. 5 x 30 minutes per week, for 12 weeks.
干预措施: internet-based adaptive cognitive control training program (Behavioral)
control group
Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 12 weeks.
干预措施: placebo program (Behavioral)
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: 12 weeks
The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive control training
Auditory Verbal Learning Test (AVLT)
时间窗: 12 weeks
The study uses AVLT to assess changes in the episodic memory function after an intervention of cognitive control training
次要结局
- Functional connectivity across regions(12 weeks)
- White matter Integrity(12 weeks)
- Brain response change(12 weeks)
- Gray matter volume(12 weeks)