Mild Cognitive ImpairmentCOG-T CHDNCT05735041
Computerized Cognitive Training in Patients With Coronary Heart Disease and Mild Cognitive Impairment
A study testing Multi-domain cognitive digital therapy and Basic cognitive therapy in people with Mild Cognitive Impairment and Coronary Heart Disease, run by Beijing Anzhen Hospital at 8 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Coronary Heart Disease
- What is being tested?
- Multi-domain cognitive digital therapy and Basic cognitive therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 8 sitesChina
- Study dates
- 18 Jan 2023to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Anzhen Hospital
Beijing
Beijing Sixth Hospital
Beijing
Peking University Third Hospital
Beijing
The second hospital of Chifeng
Chifeng
Handan Central Hospital
Handan
Inner Mongolia Ordos Central Hospital Kangbashi Department
Ordos
The First Affiliated Hospital of Hebei North University
Shijiazhuang
The First Hospital of Hebei Medical University
Zhangjiakou
About this study
Official title: The Efficacy of Computerized Cognitive Training in Patients With Coronary Heart Disease and Cognitive Impairment, no Dementia: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Coronary Heart Disease
- Being tested
- Multi-domain cognitive digital therapy, Basic cognitive therapy
- Keywords
- Cognitive training, Digital therapy
- Medical subject headings
- Cognitive Dysfunction, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-domain cognitive digital therapyBehavioural
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.
Basic cognitive therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive digital therapy group | Experimental | 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. Receives: Behavioral: Multi-domain cognitive digital therapy |
| Positive control group | Active comparator | Computer-based cognitive training tasks with low or no difficulty variation for 30 minutes at least five times a week for 12 weeks Receives: Behavioral: Basic cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks after randomization
Secondary outcomes (7)
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).
Measured: 24 weeks after randomization
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.
Measured: 12 weeks, 24 weeks after randomization
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.
Measured: 12 weeks, 24 weeks after randomization
Self-efficacy score
Mean change from baseline in self-efficacy score measured by the General Self-Efficacy Scale at 12 weeks, and 24 weeks
Measured: 12 weeks, 24 weeks after randomization
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.
Measured: 12 weeks, 24 weeks after randomization
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.
Measured: 12 weeks, 24 weeks after randomization
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.
Measured: 12 weeks, 24 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start18 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Beijing Anzhen HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Wispirit Technology Co., Ltd
- Responsible party
- Principal investigator, Yong Zeng, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05735041
- Sponsor's protocol ID
- 2022BFAZ02
- Acronym
- COG-T CHD
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ye Y, Wang D, Han J, Li S, Chen M, Sun Y, Li F, Tian H, Wang L, Zhao W, Ning X, Chen Q, Wang X, Ma C, Liu X, Zeng Y. Neural changes after computerized cognitive training in coronary heart disease with mild cognitive impairment: secondary analysis of a randomized clinical trial. Alzheimers Res Ther. 2026 Jun 25. doi: 10.1186/s13195-026-02116-2. Online ahead of print.
PubMed 42351238Chen Q, Ye Y, Liu X, Ding Y, Sun Y, Li F, Tian H, Wang L, Zhao W, Ning X, Li S, Wang X, Zeng Y. Efficacy of computerised cognitive training in patients with coronary heart disease and mild cognitive impairment: a randomised controlled trial. Heart. 2026 May 4:heartjnl-2025-327472. doi: 10.1136/heartjnl-2025-327472. Online ahead of print.
PubMed 42082334Ye Y, Chen Q, Li R, Wang X, Sun Y, Li F, Liu X, Wang L, Ning X, Tian H, Zhao W, Ma C, Zhang H, Zeng Y. The efficacy of computerized cognitive training in patients with coronary heart disease and cognitive impairment, no dementia: study protocol for a randomized controlled trial. Trials. 2025 Feb 21;26(1):64. doi: 10.1186/s13063-025-08745-6.
PubMed 39985041
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Computerized Cognitive Training in Patients With Coronary Heart Disease and Cognitive Impairment, no Dementia: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05735041
- Acronym / sponsor ID
- COG-T CHD / 2022BFAZ02
- Conditions
- Mild Cognitive Impairment, Coronary Heart Disease
- Keywords
- Cognitive training, Digital therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Collaborators
- Beijing Wispirit Technology Co., Ltd
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive digital therapy group | Experimental | Behavioral: Multi-domain cognitive digital therapyComputer-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 | Active comparator | Behavioral: Basic cognitive therapyComputer-based cognitive training tasks with low or no difficulty variation for 30 minutes at least five times a week for 12 weeks |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (14 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-domain cognitive digital therapyPatients 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. | Behavioural | Cognitive digital therapy group |
| Basic cognitive therapyThe 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. | Behavioural | Positive control group |
Primary outcome
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.
7 secondary outcomes
Global cognitive function change measured by BCAT in 24 weeks
Time frame: 24 weeks after randomization
Sub-domain cognitive function improvement including memory, attention, and execution memory
Time frame: 12 weeks, 24 weeks after randomization
Cognitive score change
Time frame: 12 weeks, 24 weeks after randomization
Self-efficacy score
Time frame: 12 weeks, 24 weeks after randomization
Quality of life score
Time frame: 12 weeks, 24 weeks after randomization
Anxiety score
Time frame: 12 weeks, 24 weeks after randomization
Depression score
Time frame: 12 weeks, 24 weeks after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Derived from this study: PubMed 42351238Ye Y, Wang D, Han J, Li S, Chen M, Sun Y, Li F, Tian H, Wang L, Zhao W, Ning X, Chen Q, Wang X, Ma C, Liu X, Zeng Y. Neural changes after computerized cognitive training in coronary heart disease with mild cognitive impairment: secondary analysis of a randomized clinical trial. Alzheimers Res Ther. 2026 Jun 25. doi: 10.1186/s13195-026-02116-2. Online ahead of print.
- Derived from this study: PubMed 42082334Chen Q, Ye Y, Liu X, Ding Y, Sun Y, Li F, Tian H, Wang L, Zhao W, Ning X, Li S, Wang X, Zeng Y. Efficacy of computerised cognitive training in patients with coronary heart disease and mild cognitive impairment: a randomised controlled trial. Heart. 2026 May 4:heartjnl-2025-327472. doi: 10.1136/heartjnl-2025-327472. Online ahead of print.
- Derived from this study: PubMed 39985041Ye Y, Chen Q, Li R, Wang X, Sun Y, Li F, Liu X, Wang L, Ning X, Tian H, Zhao W, Ma C, Zhang H, Zeng Y. The efficacy of computerized cognitive training in patients with coronary heart disease and cognitive impairment, no dementia: study protocol for a randomized controlled trial. Trials. 2025 Feb 21;26(1):64. doi: 10.1186/s13063-025-08745-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-domain cognitive digital therapy and Basic cognitive therapy in people with Mild Cognitive Impairment and Coronary Heart Disease, run by Beijing Anzhen Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognitive function change measured by BCAT in 12 weeks (time frame: 12 weeks after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05735041, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.