Computerized Cognitive Training in Patients With Coronary Heart Disease and Mild Cognitive Impairment - Clinical Trial for Mild Cognitive Impairment | NCT05735041

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Multi-domain cognitive digital therapy

Basic cognitive therapy

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Cognitive training, Digital therapy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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; Prior neurosurgery or history of cranial tumors; Nuclear magnetic examination contraindications: such as metal implants, claustrophobia, etc.; patients living alone; Patients with atrial fibrillation, structural heart disease, and infective endocarditis.

Sites / Locations

Beijing Anzhen HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cognitive digital therapy group

Positive control group

Arm 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.

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

Outcomes

Primary Outcome Measures

Global cognitive function change measured by BCAT in 12 weeks

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

Global cognitive function change measured by BCAT in 24 weeks

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).

Sub-domain cognitive function improvement including memory, attention, and execution memory

The proportion of patients whose sub-domain cognitive function, including attention, memory, execution function improves measured by the individual capability test in BCAT.

Cognitive score change

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

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

Mean change from baseline in the patient's quality of life score measured by EQ-5D-3L at 12 weeks and 24 weeks.

Anxiety score

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

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.

Full Information

NCT ID

NCT05735041

First Posted

February 9, 2023

Last Updated

February 9, 2023

Sponsor

Beijing Anzhen Hospital

Collaborators

Beijing Wispirit Technology Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05735041

Brief Title

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

Acronym

COG-T CHD

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

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 18, 2023 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Beijing Anzhen Hospital

Collaborators

Beijing Wispirit Technology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In this study, a 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 double-blinded, randomized controlled trial. A total of 200 CHD patients with mild cognitive impairment will be recruited after the 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment, Coronary Heart Disease

Keywords

Cognitive training, Digital therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cognitive digital therapy group

Arm Type

Experimental

Arm 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.

Arm Title

Positive control group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Multi-domain cognitive digital therapy

Intervention Description

Patients in the cognitive digital therapy group received multi-dimensional targeted cognitive function training electronically, involving attention, memory, executive function, thinking, processing speed and perception. The system will adjust the training difficulty and training plan adaptively according to the patient's current training time and performance, and train the patient's weak cognitive ability as far as possible. The patients had the same total amount of training each day.

Intervention Type

Behavioral

Intervention Name(s)

Basic cognitive therapy

Intervention Description

The training content of the positive control group was cognitive training tasks with weak difficulty or no difficulty change. The patients underwent cognitive function training with fixed programs, including 15 training items, and the internal difficulty of the training items remained constant without change. The system presents the training content randomly according to the training scheme. The patients had the same total amount of training each day.

Primary Outcome Measure Information:

Title

Global cognitive function change measured by BCAT in 12 weeks

Description

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.

Time Frame

12 weeks after randomization

Secondary Outcome Measure Information:

Title

Global cognitive function change measured by BCAT in 24 weeks

Description

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).

Time Frame

24 weeks after randomization

Title

Sub-domain cognitive function improvement including memory, attention, and execution memory

Description

The proportion of patients whose sub-domain cognitive function, including attention, memory, execution function improves measured by the individual capability test in BCAT.

Time Frame