NCT05374642

Atrial Fibrillation Follow-up Investigation to Recover Memory and learnING Trial

Randomized Controlled Trial of Computerized Cognitive Training in Patients With Atrial Fibrillation With Cognitive Impairment But Without Dementia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to evaluate the effectiveness of cognitive training in people with atrial fibrillation and cognitive decline over 12-week cognitive training. Moreover, the investigators will explore whether the training effect can be maintained.

Detailed description

Introduction: Cognitive impairment is a clinical condition characterized of a reduction in memory and/or other cognitive processes that are insufficiently severe to be diagnosed as dementia.The prevalence of dementia among people over 65 years old in China is 5.14% , while the prevalence of mild cognitive impairment is 20.8%. The risk of cognitive impairment and dementia in patients with atrial fibrillation is significantly higher than that those in the same age group, even after adjusted stroke and other common risk factors such as hypertension and diabetes. At present, the effectiveness of cognitive training in patients with atrial fibrillation complicated with cognitive impairment is not clear. Objectives: The objective of the study is to evaluate whether cognitive training could lead cognitive improvement in patients with cognitive impairment and atrial fibrillation. Patients and Methods: The proposed study is a double blinded, randomized and controlled trial that will include 200 patients with cognitive impairment and atrial fibrillation. The groups will be randomized to either intervention or active-control group. Both groups will receive computerized cognitive training performed for 30 minutes x 5 times/week over 12 weeks. A neuropsychological assessment will be administered at baseline and week 12 and 24 after the intervention. The structural and functional MRI will be performed at baseline and week 12 after intervention for a sub-study on the effect of cognitive training on brain structure and function.

Conditions

• Cognitive Impairment
• Atrial Fibrillation

Interventions

Type	Name	Description
BEHAVIORAL	cognitive training	tablet-based cognitive training for 12 weeks, 30 minutes each time, at least 5 times a week
BEHAVIORAL	active control	tablet-based cognitive training tasks with weak or no difficulty changes, 5 times a week, 30 minutes each time for 12 weeks

Timeline

• Start date: 2022-09-19
• Primary completion: 2023-12-22
• Completion: 2024-03-27
• First posted: 2022-05-16
• Last updated: 2024-05-24

Locations

1 site across 1 country: China