The Efficacy of Computerized Cognitive Training in Patients With Hypertension and Cognitive Impairment, no Dementia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Global cognitive function change measured by BCAT in 12 weeks
研究概览
简要总结
Hypertension is an risk factor for cognitive impairment. The primary objective of this study is to evaluate the efficacy of 12-week computerized cognitive training in people with hypertension and mild cognitive impairment. The researchers will further investigate the long-term effects of cognitive training by prolonging the intervention for 24 weeks among a randomly selected sub-group.
详细描述
This study is a double-blinded, randomized controlled trial. A total of 200 hypertension patients with mild cognitive impairment will be recruited to participate in this study after screening. These patients will be randomized to two arms under masking. The intervention arm will receive multi-domain adaptive cognitive training using a tablet. The control arm will receive an active control treatment and use the same tablet to receive the cognitive training tasks with weak difficulty change. Both arms will receive the same intervention dosage for 12 weeks, 5 times a week, and 30 minutes per time. After the 12-week intervention, the intervention arm will be re-randomized into two groups. One group will stop their intervention at 12 weeks; the other group will continue to receive the multi-domain adaptive cognitive training till the 24-week follow-up assessment.
The neuro-psychological assessment will be administered at baseline, 12-week, and 24-week assessments for all participants. The structural and functional MRI will be administered at baseline, 12 weeks, and 24 weeks to evaluate the effect of cognitive training on brain structure and function.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older than 60 years;
- •Completed 6 or more years of education;
- •Untreated or under treatment hypertension;
- •Complaint of memory decline within 1 year;
- •Global cognitive score measured by the Montreal Cognitive Assessment is below 26;
- •Agree to receive cognitive function evaluation, randomization, and follow-up investigation as required;
排除标准
- •Unable to complete cognitive function evaluation due to vision, hearing, and other problems;
- •Have been diagnosed of dementia or MMSE score ≤ 20;
- •Unable to use the cognitive training equipment after 2 times instructions;
- •Alcohol abuse or taking drugs that could affect cognitive function (antihistamines, antipsychotics);
- •Diabetes patients;
- •Moderate to severe decrease in glomerular filtration rate (eGFR<30 ml/min /1.73m2);
- •Systolic blood pressure ≥180 mmHg or/and diastolic blood pressure ≥110 mmHg; or orthostatic hypotension (defined as the third standing SBP<100mmHg);
- •History of cardiovascular events or hospitalization due to cardiovascular diseases in the last 3 months;
- •Planned to receive coronary intervention, atrial fibrillation ablation or cardiac surgery within 6 months; or have received these intervention strategies in the last 3 months;
- •Symptomatic heart failure or left ventricular ejection fraction <50%；
- •Atrial fibrillation confirmed by ECG with marked and severe onset of symptoms;
- •A history of stroke, or head injury in the last 6 months; past history of brain tumor or neurosurgery;
- •Past history of Parkinson's disease, Alzheimer's disease, schizophrenia, and epilepsy;
- •Have Ever undergone surgery under general anesthesia in the last three months;
- •Severe hepatic impairment or in critical condition patients with very poor prognosis whose expected survival is less than 6 months; or diagnosed of malignant tumor other than non-melanoma skin cancer in the last 2 years;
- •Contradictions for MRI examination: such as metal implantation, claustrophobia, etc.;
- •Unable to obtain an informed consent or currently taking part in other clinical trials
结局指标
主要结局
Global cognitive function change measured by BCAT in 12 weeks
时间窗: 12 weeks after randomization
The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function measured by Basic Cognitive Ability Test (BCAT). BCAT is a set of neuropsychological battery tests which was designed to measure global cognitive fucntion and cognitive function of sub-domains. Higher scores of BCAT means a better global cognitive function.
次要结局
- Quality of life score(12 weeks, 24 weeks after randomization)
- Global cognitive function change measured by BCAT in 24 weeks(24 weeks after randomization)
- Cognitive score change(12 weeks, 24 weeks after randomization)
- Sub-domain cognitive function improvement including memory, attention, and execution memory(12 weeks, 24 weeks after randomization)
- Anxiety score(12 weeks, 24 weeks after randomization)
- Self-efficacy score(12 weeks, 24 weeks after randomization)
- Depression score(12 weeks, 24 weeks after randomization)
研究者
Chang sheng Ma
Professor
Beijing Anzhen Hospital