Computerized Cognitive Training in Patients With Coronary Heart Disease and Mild Cognitive Impairment

Not Applicable

Active, not recruiting

• Conditions: Mild Cognitive Impairment; Coronary Heart Disease
• Interventions: Behavioral: Multi-domain cognitive digital therapy; Behavioral: Basic cognitive therapy

• Registration Number: NCT05735041
• Lead Sponsor: Beijing Anzhen Hospital

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.

Study Timeline

• Study Start: 2023-01-18
• Study First Submitted: 2023-02-09
• Study First Submitted QC: 2023-02-09
• Study First Posted: 2023-02-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-20
• Last Update Posted: 2024-02-21
• Primary Completion: 2024-12-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 224

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive digital therapy group	Multi-domain cognitive digital therapy	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.
Positive control group	Basic cognitive therapy	Computer-based cognitive training tasks with low or no difficulty variation for 30 minutes at least five times a week for 12 weeks

Primary Outcome Measures

Name	Time	Method
Global cognitive function change measured by BCAT in 12 weeks	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 Outcome Measures

Name	Time	Method
Global cognitive function change measured by BCAT in 24 weeks	24 weeks after randomization	The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function at 24 weeks measured by Basic cognitive Ability Test(BCAT).
Cognitive score change	12 weeks, 24 weeks after randomization	Mean change from baseline in global cognitive function score measured by basic cognitive ability test (BCAT) at 12 weeks and 24 weeks.
Self-efficacy score	12 weeks, 24 weeks after randomization	Mean change from baseline in self-efficacy score measured by the General Self-Efficacy Scale at 12 weeks, and 24 weeks
Quality of life score	12 weeks, 24 weeks after randomization	Mean change from baseline in the patient's quality of life score measured by EQ-5D-3L at 12 weeks and 24 weeks.
Sub-domain cognitive function improvement including memory, attention, and execution memory	12 weeks, 24 weeks after randomization	The proportion of patients whose sub-domain cognitive function, including attention, memory, execution function improves measured by the individual capability test in BCAT.
Anxiety score	12 weeks, 24 weeks after randomization	Mean change from baseline in the patient's anxiety score at 12 weeks and 24 weeks. Anxiety status will be measured by GAD-7 questionnaire. Higher score of GAD-7 scale represents more anxiety status.
Depression score	12 weeks, 24 weeks after randomization	Mean change from baseline in the patient's depression score at 12 weeks and 24 weeks. Depression status will be measured by PHQ-9 questionnaire. Higher score of PHQ-9 scale represents more depression status.

Trial Locations

Locations (8)

The second hospital of Chifeng; 🇨🇳 Chifeng, China

Inner Mongolia Ordos Central Hospital Kangbashi Department; 🇨🇳 Ordos, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, China

The First Hospital of Hebei Medical University; 🇨🇳 Zhangjiakou, China

Handan Central Hospital; 🇨🇳 Handan, China

The First Affiliated Hospital of Hebei North University; 🇨🇳 Shijiazhuang, China

Peking University Third Hospital; 🇨🇳 Beijing, China

Beijing Sixth Hospital; 🇨🇳 Beijing, China