NCT06524388

Adaptive Cognitive Training on Cognitive Function in Elderly Diabetes Patients in the Community

The Effects of COgNitive Training in Community-dwelling Older Adults at High Risk for demENTia and With Diabetes (CONTENT-Diabetes): a Randomized, Placebo-controlled Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fanfan Zheng · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

Objective A growing body of evidence supports diabetes as a risk factor for cognitive decline. Diabetes is significantly associated with accelerated cognitive decline, poorer cognitive function, and mild cognitive impairment and dementia. Cognitive training is an effective intervention to improve cognitive function. However, the current cognitive training does not fully consider the different areas and degrees of cognitive function impairment of older adults. This study aims to evaluate the effect of adaptive cognitive training on cognitive function of older adults with hypertension in the community. Participants Age 60 years or older, diagnosis of diabetes, fasting blood glucose≥6.1mmol/L and cognitive function assessment showed no dementia. Design The study was designed as a double-blind randomized controlled trial. 120 diabetes participants without dementia aged 60 years or older in Shijingshan, Beijing and Haidian, Beijing were included. Participants will be randomized to adaptive cognitive training (intervention group) and placebo cognitive training (control group) at a ratio of 1:1. Both training will be delivered by using PADs with the same appearance. The interventions will last for 6 months and follow up to 12 months, and both groups will be followed up on the same time schedules for all outcome measurements. The primary outcome is changes in MoCA scores from baseline to post-intervention, 6 months. The current trial has been reviewed by the Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College (approval number: 2024-162).

Conditions

• Cognition
• Diabetes Mellitus, Type 2
• Aging

Interventions

Type	Name	Description
DEVICE	adaptive cognitive training	The intervention was computerized, multi-domain, adaptive cognitive training. Training areas include processing speed, attention, perception, long-term memory, working memory, computation, executive control, reasoning, and problem-solving. Embedded in the Adaptive Cognitive training application is an adaptive algorithm that will help provide each participant with a cognitive training task at the right level of difficulty based on their profile and real-time performance.
DEVICE	placebo cognitive training	Participants received cognitive training tasks of fixed difficulty.

Timeline

• Start date: 2024-10-29
• Primary completion: 2026-09-01
• Completion: 2027-06-01
• First posted: 2024-07-29
• Last updated: 2025-12-04

Locations

1 site across 1 country: China