NCT05704270

Computerized Cognitive Training to Protect Cognitive Function Among Hypertension Patients

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Hypertension is an risk factor for cognitive impairment. The primary objective of this study is to evaluate the efficacy of 12-week computerized cognitive training in people with hypertension and mild cognitive impairment. The researchers will further investigate the long-term effects of cognitive training by prolonging the intervention for 24 weeks among a randomly selected sub-group.

Detailed description

This study is a double-blinded, randomized controlled trial. A total of 200 hypertension patients with mild cognitive impairment will be recruited to participate in this study after 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.

Conditions

• Mild Cognitive Impairment
• Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Multi-domain adaptive cognitive training	The multi-domain adaptive cognitive training covers seven aspects of fundamental cognitive function, including sensory perception, cognitive flexibility, attention, memory, language, logic calculation, and emotion recognition and management. A self-adaptive algorithm is embedded in the tablet-based cognitive training platform, which will help deliver suitable tasks at the right difficulty level for each participant according to their personal profile and real-time performance. The intervention dosage is 30 minutes per time, 5 times a week.
BEHAVIORAL	Basic cognitive training with no difficulty change	The basic cognitive training for the control arm will also be delivered via a tablet. The training tasks will be fixed at a primary difficulty level without adaptive algorithm. The intervention dosage is also 30 minutes per time, 5 times a week.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-12-31
• Completion: 2025-03-30
• First posted: 2023-01-30
• Last updated: 2023-01-30

Locations

2 sites across 1 country: China