Computerized Cognitive Training in Patients With Coronary Heart Disease and Mild Cognitive Impairment (COG-T CHD)

Capital Medical University

Status: Active, not recruiting

Conditions: Coronary Heart Disease; Mild Cognitive Impairment

Treatments: Behavioral: Basic cognitive therapy; Behavioral: Multi-domain cognitive digital therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05735041

2022BFAZ02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 224 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Over the age of 50;
2. Completion of more than 6 years of education;
3. Patients with coronary artery disease confirmed by coronary CT angiography or coronary angiography;
4. Chief complaint of cognitive decline within 1 year;
5. 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;
6. Agree to be randomized to cognitive function tests and cognitive training and be able to receive follow-up as required.

Exclusion criteria

1. Previous definite diagnosis of dementia or brief Mental State Examination Scale (MMSE) < 24 points;
2. Cognitive dysfunction caused by cranial trauma, cranial tumor, Parkinson's disease, schizophrenia, Alzheimer's disease, anxiety and depression, and other neuropsychiatric diseases;
3. Deaf and mute or other reasons cannot communicate normally;
4. Binge drinking or taking drugs (antihistamines, antipsychotics) that affect cognitive function;
5. Unable to master the use of cognitive training equipment after two 1-hour training instructions each time;
6. Patients who plan to undergo coronary intervention within 6 months or have undergone coronary intervention within 1 month;
7. Severe liver and kidney function injury or critical condition, poor prognosis, estimated survival of less than 1 month.
8. Patients who had received general anesthesia within 3 months;
9. History of stroke and craniocerebral trauma within 6 months;
10. History of Parkinson's disease, schizophrenia, and epilepsy;
11. Prior neurosurgery or history of cranial tumors;
12. Nuclear magnetic examination contraindications: such as metal implants, claustrophobia, etc.;
13. patients living alone;
14. Patients with atrial fibrillation, structural heart disease, and infective endocarditis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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224 participants in 2 patient groups

Cognitive digital therapy group

Experimental group

Description:

Computer-based cognitive training for 30 minutes at least 5 times a week for 12 weeks; At the end of the 12 weeks, the subjects were randomly divided into two groups. One group continued the training for 12 weeks, at least five times a week for 30 minutes each time, and the other group stopped the training.

Treatment:

Behavioral: Multi-domain cognitive digital therapy

Positive control group

Active Comparator group

Description:

Computer-based cognitive training tasks with low or no difficulty variation for 30 minutes at least five times a week for 12 weeks

Treatment:

Behavioral: Basic cognitive therapy