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

Last updated: February 20, 2024
Sponsor: Beijing Anzhen Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Coronary Artery Disease

Memory Loss

Chest Pain

Treatment

Multi-domain cognitive digital therapy

Basic cognitive therapy

Clinical Study ID

NCT05735041
2022BFAZ02
  • Ages > 50
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 coronaryangiography;
  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) isless than 1 SD compared with the normal population;
  6. Agree to be randomized to cognitive function tests and cognitive training and be ableto receive follow-up as required.

Exclusion

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 neuropsychiatricdiseases;
  3. Deaf and mute or other reasons cannot communicate normally;
  4. Binge drinking or taking drugs (antihistamines, antipsychotics) that affect cognitivefunction;
  5. Unable to master the use of cognitive training equipment after two 1-hour traininginstructions each time;
  6. Patients who plan to undergo coronary intervention within 6 months or have undergonecoronary 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 infectiveendocarditis.

Study Design

Total Participants: 224
Treatment Group(s): 2
Primary Treatment: Multi-domain cognitive digital therapy
Phase:
Study Start date:
January 18, 2023
Estimated Completion Date:
July 31, 2025

Study 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.

Connect with a study center

  • Beijing Anzhen Hospital

    Beijing,
    China

    Site Not Available

  • Beijing Sixth Hospital

    Beijing,
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing,
    China

    Site Not Available

  • The second hospital of Chifeng

    Chifeng,
    China

    Site Not Available

  • Handan Central Hospital

    Handan,
    China

    Site Not Available

  • Inner Mongolia Ordos Central Hospital Kangbashi Department

    Ordos,
    China

    Site Not Available

  • The First Affiliated Hospital of Hebei North University

    Shijiazhuang,
    China

    Site Not Available

  • The First Hospital of Hebei Medical University

    Zhangjiakou,
    China

    Site Not Available

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