The Efficacy of Computerized Cognitive Training in Patients With Coronary Heart Disease and Cognitive Impairment, no Dementia: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Beijing Anzhen Hospital
- Enrollment
- 224
- Locations
- 8
- Primary Endpoint
- Global cognitive function change measured by BCAT in 12 weeks
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
In this study, a multicentre, double-blind, randomized controlled study based on cognitive training was conducted in patients with coronary heart disease and cognitive impairment but without dementia， to evaluate the effectiveness of computer-based digital therapy in improving the cognitive function of such patients.
Detailed Description
This study is a multicentre, double-blind, parallel randomized controlled study using a 1:1 parallel control design. A total of 200 patients with coronary heart disease combined with cognitive decline but no dementia were enrolled in 8 centres. 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.
Investigators
Yong Zeng
Professor
Beijing Anzhen Hospital
Eligibility Criteria
Inclusion Criteria
- •Over the age of 50;
- •Completion of more than 6 years of education;
- •Patients with coronary artery disease confirmed by coronary CT angiography or coronary angiography;
- •Chief complaint of cognitive decline within 1 year;
- •The average score of any cognitive domain in processing speed, situational memory, working memory and visual space measured by the Basic Cognitive Ability Test (BCAT) is less than 1 SD compared with the normal population;
- •Agree to be randomized to cognitive function tests and cognitive training and be able to receive follow-up as required.
Exclusion Criteria
- •Previous definite diagnosis of dementia or brief Mental State Examination Scale (MMSE) \< 24 points;
- •Cognitive dysfunction caused by cranial trauma, cranial tumor, Parkinson's disease, schizophrenia, Alzheimer's disease, anxiety and depression, and other neuropsychiatric diseases;
- •Deaf and mute or other reasons cannot communicate normally;
- •Binge drinking or taking drugs (antihistamines, antipsychotics) that affect cognitive function;
- •Unable to master the use of cognitive training equipment after two 1-hour training instructions each time;
- •Patients who plan to undergo coronary intervention within 6 months or have undergone coronary intervention within 1 month;
- •Severe liver and kidney function injury or critical condition, poor prognosis, estimated survival of less than 1 month.
- •Patients who had received general anesthesia within 3 months;
- •History of stroke and craniocerebral trauma within 6 months;
- •History of Parkinson's disease, schizophrenia, and epilepsy;
Outcomes
Primary Outcomes
Global cognitive function change measured by BCAT in 12 weeks
Time Frame: 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.
Secondary Outcomes
- Global cognitive function change measured by BCAT in 24 weeks(24 weeks after randomization)
- Cognitive score change(12 weeks, 24 weeks after randomization)
- Self-efficacy score(12 weeks, 24 weeks after randomization)
- Quality of life score(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)
- Depression score(12 weeks, 24 weeks after randomization)