The Cog-VACCINE Study: a Randomized Controlled Clinical Trial to Evaluate the Effect of Cognitive Training in Patients With Vascular Cognitive Impairment, no Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Estimated Mean Change of the Trail Making Test (TMT) B-A
研究概览
简要总结
This study evaluates the efficacy and mechanism of internet-based cognitive training in patients with subcortical VCIND. Half of participants will receive multi-domain adaptive internet-based training program, while the other half will receive a fixed, primary difficulty level task.
详细描述
Background:
Vascular cognitive impairment no dementia (VCIND) refers to cognitive deficits associated with underlying vascular causes which fall short of a dementia diagnosis. Because of its high prevalence and high progression to dementia, interest in VCIND has greatly expanded in recent years. Although it has been widely recognized that early intervention of VCIND holds the potential to delay or even reverse the cognitive impairment, no treatment is available yet. Executive dysfunction is the characteristic impairment in subcortical VCIND, and cognitive training significantly improved executive and other aspects of cognitive function in health older adults and patients with cognitive impairment. Whether and how cognitive training improves cognitive function in patients with VCIND remains largely unknown.
Objectives:
The primary objective of this double-blinded, randomized RCT is to assess whether internet-based cognitive training in patients with subcortical VCIND improves their cognitive abilities. The second objective is to evaluate the effect of cognitive training on neural plasticity, including brain activation and white matter integrity, which are assessed by functional and structural MRI. Finally, possible genetic and plasma biomarkers related to a positive effect or lack of effect of the training will be examined.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Literate Han Chinese, aged 50-78 years, with a consistent caregiver who accompanies the subject at least 4 days a week;
- •Complaint and/or informant report of cognitive impairment involving memory and/or other cognitive domains lasting for at least 3 months;
- •Neither normal nor demented according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, with a clinical dementia rating (CDR) ≥ 0.5 on at least one domain and global score ≤ 0.5; a Mini-Mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above);
- •Normal or slightly impaired activities of daily living as defined by a total score of ≤ 1.5 on the three functional CDR domains (home and hobbies, community affairs, and personal care).
- •The MRI entry criteria are as follows:
- •Multiple (≥ 3) supratentorial subcortical small infarcts (3-20 mm in diameter), with/without white matter lesions (WML) of any degree; or moderate to severe WML (score ≥ 2 according to the Fazekas rating scale) with/without small infarct;
- •Absence of cortical and watershed infarcts, hemorrhages, hydrocephalus, and WMLs with specific causes (e.g., multiple sclerosis);
- •No hippocampal or entorhinal cortex atrophy (score 0 according to the medial temporal lobe atrophy scale of Scheltens).
排除标准
- •severe aphasia, physical disabilities, or any other factor that may preclude completion of neuropsychological testing;
- •disorders other than subcortical VCIND that may affect cognition;
- •a Hamilton depression scale (HAMD) score >17 or schizophrenia;
- •new strokes within 3 months before baseline;
- •inherited or inflammatory small vessel disease;
- •clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular system disease;
- •cancer, alcoholism, drug addiction;
- •use of medications that may affect cognitive functioning, including tranquilizers, anti-anxiolytics, hypnotics, nootropics, and cholinomimetic agents;
- •inability to undergo a brain MRI.
结局指标
主要结局
Estimated Mean Change of the Trail Making Test (TMT) B-A
时间窗: Baseline and 7 weeks
The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The change from baseline at week 7 in the B-A difference is reported as a primar
Estimated Mean Change of the Montreal Cognitive Assessment (MoCA)
时间窗: Baseline and 7 weeks
The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive training. Baseline and 7-week were the two relevant time points used in the calculation. The score of MoCA ranges from 0 to 30, and higher scores mean a better outcome.
次要结局
- Estimated Mean Changes in Left Hippocampal Volume(Baseline and 7 weeks)
- Estimated Mean Change in Right Hippocampal Volume(Baseline and 7 weeks)
- Estimated Mean Change in Brain White Matter Integrity(Baseline and 7 weeks)
研究者
Yi Tang
Dr.
Beijing Friendship Hospital