NCT05735041

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

The Efficacy of Computerized Cognitive Training in Patients With Coronary Heart Disease and Cognitive Impairment, no Dementia: a Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mild Cognitive Impairment
• Coronary Heart Disease

Interventions

Type	Name	Description
BEHAVIORAL	Multi-domain cognitive digital therapy	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.
BEHAVIORAL	Basic cognitive therapy	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.

Timeline

• Start date: 2023-01-18
• Primary completion: 2024-12-31
• Completion: 2025-07-31
• First posted: 2023-02-21
• Last updated: 2024-02-21

Locations

8 sites across 1 country: China