The Effects of COgNitive Training in Community-dwelling Older Adults at High Risk for demENTia and With Diabetes (CONTENT-Diabetes): a Randomized, Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Montreal Cognitive Assessment (MoCA)
研究概览
简要总结
Objective A growing body of evidence supports diabetes as a risk factor for cognitive decline. Diabetes is significantly associated with accelerated cognitive decline, poorer cognitive function, and mild cognitive impairment and dementia. Cognitive training is an effective intervention to improve cognitive function. However, the current cognitive training does not fully consider the different areas and degrees of cognitive function impairment of older adults. This study aims to evaluate the effect of adaptive cognitive training on cognitive function of older adults with hypertension in the community.
Participants Age 60 years or older, diagnosis of diabetes, fasting blood glucose≥6.1mmol/L and cognitive function assessment showed no dementia.
Design The study was designed as a double-blind randomized controlled trial. 120 diabetes participants without dementia aged 60 years or older in Shijingshan, Beijing and Haidian, Beijing were included. Participants will be randomized to adaptive cognitive training (intervention group) and placebo cognitive training (control group) at a ratio of 1:1. Both training will be delivered by using PADs with the same appearance. The interventions will last for 6 months and follow up to 12 months, and both groups will be followed up on the same time schedules for all outcome measurements. The primary outcome is changes in MoCA scores from baseline to post-intervention, 6 months. The current trial has been reviewed by the Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (approval number: 2024-162).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with a clear diagnosis of diabetes (according to ICD-10 or DSM-criteria), fasting blood glucose≥6.1mmol/L, maintaining the original diabetes treatment strategy
- •age ≥60 years old
- •literate and able to use smart phone or tablet computer skillfully, with CAIDE dementia risk score >9, but without a diagnosis of dementia (ICD-10 or DSM-dementia diagnostic criteria)
- •have lived in the target community for at least 6 months and continue to live in the original community for the next 12 months
排除标准
- •Stroke or brain surgery in the previous 12 months
- •Alcohol or drug abuse in the past 12 months
- •Families, important people of participants in the study have concerns
- •Live in the same household as a participant who has been randomly assigned
- •Severe aphasia, physical disability, or any other factor that may prevent completion of neuropsychological testing
- •Use of medications that may affect cognition, including sedatives, anxiolytics, hypnotics, nootropics, and cholinergic drugs; Refusing or not receiving cognitive training
- •currently participating in another clinical trial.
结局指标
主要结局
Montreal Cognitive Assessment (MoCA)
时间窗: baseline; "post-intervention, 12weeks"
MoCA has been widely used in the cognitive function assessment of middle-aged and elderly people in China, including executive function, memory, orientation, computation, conceptual thinking, visual perception, language, and attention. The MoCA scale scores ranged from 0 to 30, and the lower the score, the worse the cognitive function.
次要结局
- Montreal Cognitive Assessment (MoCA)(baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up)
- the Trail Making Test (TMT)(baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up)
- the WHO-UCLA Auditory Verbal Learning Test(AVLT)(baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up)
- Generalized Anxiety Disorder-7 (GAD-7)(baseline; 6 week-intervention; "post-intervention, 12 weeks")
- the Digit Symbol Substitution Test (DSST)(baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up)
- the Boston Naming Test (BNT)(baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up)
- Geriatric Depression Scale (GDS)(baseline; 6 week-intervention; "post-intervention, 12 weeks")
- Pittsburgh sleep quality index (PSQI)(baseline; 6 week-intervention; "post-intervention, 12 weeks")
- fasting blood glucose(baseline; "post-intervention, 12 weeks")
研究者
Fanfan Zheng
Principal Investigator
Peking Union Medical College