Effects of 24-week Computerized Cognitive Training on Microbiota-gut-brain Axis in Patients With Mild Cognitive Impairment and Mild Alzheimer's Disease: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Global Cognition
研究概览
简要总结
This study aims to testify multi-domain effects of computerized cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease through multi-dimensional evaluation.
详细描述
This study aimed to elucidate the neural process enhancement and remodulation in gut microbes resulting from older adults with MCI and mild AD in a randomized controlled trial of a 24-week computerized cognitive training (CCT) program.
After recruitment and baseline assessments, pairs of participants with MCI and mild AD would be randomly allocated into the corresponding subgroup. Participants in CCT group will receive a computerized multidomain cognitive training program (www.66nao.com) and will be required to complete at least 30 minutes of training per day (3 cycle of 5 2-min tasks), 5 days a week for 24 weeks. Adherence to the intervention will be supervised by an independent researcher. The number of training days and training hours per day will be recorded. Patients in control group received treatment as usual (TAU) for 24 weeks. The neuropsychological measures will be performed at baseline, follow-up at 4 weeks, 12 weeks, and 24 weeks; functional Near-Infrared Spectroscopy (fNIRS) data and fecal samples will collected at baseline and 24 weeks.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Since it will not be possible to blind the participants because the experimental and control interventions have to be explained to them and their caregivers before randomization. The single blinding will be applied to researchers who conducted the measurements to minimize the potential assessor biases. Blinding will be also maintained for data management, outcome assessment, and data analysis.
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 55 and 90 years of age;
- •a Clinical Dementia Rating (CDR) score of 0.5 or 1;
- •at least three months of stable doses if receiving antidementia medication or mood-stabilizing medication for mild AD participants;
- •primary school education and above;
- •accompanied by a consistent caregiver (at least 5 days/week);
- •informed consent.
排除标准
- •factors that might preclude completion of assessments;
- •severe psychiatric illness and the use of antidepressants;
- •any condition that would preclude completion of training and follow-up tests;
- •other disorders that would affect cognition.
结局指标
主要结局
Global Cognition
时间窗: baseline, 4, 12, 24 weeks
The Alzheimer's Disease Assessment Scale- cognitive subscale (11 items) will be used to evaluate global cognition and served as the primary outcome measure. The minimum and maximum values are 0 and 70 respectively, and higher scores mean a worse outcome.
次要结局
- Learning(baseline, 4, 12, 24 weeks)
- Episodic Memory(baseline, 4, 12, 24 weeks)
- Depression(baseline, 4, 12, 24 weeks)
- Brain Functional Connectivity(baseline and 24 weeks)
- Beta-diversity of Gut Microbiome(baseline and 24 weeks)
- Severity of Cognitive Impairment(baseline, 4, 12, 24 weeks)
- Visuospatial Function(baseline, 4, 12, 24 weeks)
- Verbal Frequency(baseline, 4, 12, 24 weeks)
- Daily Living Function(baseline, 4, 12, 24 weeks)
- Attention(baseline, 4, 12, 24 weeks)
- Verbal Ability(baseline, 4, 12, 24 weeks)
- Executive Function(baseline, 4, 12, 24 weeks)
- Neuropsychiatric Symptoms(baseline, 4, 12, 24 weeks)
- Alpha-diversity of Gut Microbiome(baseline and 24 weeks)
- Composition of Gut Microbiome(baseline and 24 weeks)
研究者
Wenbo Zhang
Principle Investigator
Chongqing Medical University