Clinical trial NCT05735041: Computerized Cognitive Training in Patients With Coronary Heart Disease and Mild Cognitive Impairment
Official title: The Efficacy of Computerized Cognitive Training in Patients With Coronary Heart Disease and Cognitive Impairment, no Dementia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Coronary Heart Disease
Keywords: Cognitive training
Digital therapy
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Wispirit Technology Co., Ltd
First posted: 2023-02-21
Enrollment: 224
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Global cognitive function change measured by BCAT in 12 weeks
timeFrame: 12 weeks after randomization
Secondary outcomes:
measure: Global cognitive function change measured by BCAT in 24 weeks
timeFrame: 24 weeks after randomization
measure: Sub-domain cognitive function improvement including memory, attention, and execution memory
timeFrame: 12 weeks, 24 weeks after randomization
measure: Cognitive score change
timeFrame: 12 weeks, 24 weeks after randomization
measure: Self-efficacy score
timeFrame: 12 weeks, 24 weeks after randomization
measure: Quality of life score
timeFrame: 12 weeks, 24 weeks after randomization
measure: Anxiety score
timeFrame: 12 weeks, 24 weeks after randomization
measure: Depression score
timeFrame: 12 weeks, 24 weeks after randomization
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
city: Beijing
country: China
facility: Beijing Sixth Hospital
city: Beijing
country: China
facility: Peking University Third Hospital
city: Chifeng
country: China
facility: The second hospital of Chifeng
city: Handan
country: China
facility: Handan Central Hospital
city: Ordos
country: China
facility: Inner Mongolia Ordos Central Hospital Kangbashi Department
city: Shijiazhuang
country: China
facility: The First Affiliated Hospital of Hebei North University
city: Zhangjiakou
country: China
facility: The First Hospital of Hebei Medical University
Study officials:
References: