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

NCT06524388 | Enrolling By Invitation

• 1 other identifier: CFH 2024-2G-4253
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Montreal Cognitive Assessment (MoCA)

  MoCA has been widely used in the cognitive function assessment of middle-aged and elderly people in China, including executive function, memory, orientation, computation, conceptual thinking, visual perception, language, and attention. The MoCA scale scores ranged from 0 to 30, and the lower the score, the worse the cognitive function.

  baseline; "post-intervention, 12weeks"

Secondary Outcomes (9)

• Montreal Cognitive Assessment (MoCA)

  baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up

• the Trail Making Test (TMT)

  baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up

• the Digit Symbol Substitution Test (DSST)

  baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up

• the WHO-UCLA Auditory Verbal Learning Test(AVLT)

  baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up

• the Boston Naming Test (BNT)

  baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up

Study Arms (2)

adaptive cognitive training

EXPERIMENTAL

The intervention lasted for 12 weeks. Participants will revieve 30 minutes of training per day, at least five days per week. In each task, once a high accuracy (e.g. \>80%) is achieved, the task is automatically upgraded to the next difficulty level.

Device: adaptive cognitive training

placebo cognitive training

PLACEBO COMPARATOR

The intervention lasted for 12 weeks. Participants will revieve 30 minutes of training per day, at least five days per week. The tasks will be set to a fixed level of difficulty.

Device: placebo cognitive training

Interventions

adaptive cognitive training DEVICE

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.

adaptive cognitive training

placebo cognitive training DEVICE

Participants received cognitive training tasks of fixed difficulty.

placebo cognitive training

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• with a clear diagnosis of diabetes (according to ICD-10 or DSM-criteria), fasting blood glucose≥6.1mmol/L, maintaining the original diabetes treatment strategy
• age ≥60 years old
• literate and able to use smart phone or tablet computer skillfully, with CAIDE dementia risk score \>9, but without a diagnosis of dementia (ICD-10 or DSM-dementia diagnostic criteria)
• have lived in the target community for at least 6 months and continue to live in the original community for the next 12 months

You may not qualify if:

• Stroke or brain surgery in the previous 12 months
• Alcohol or drug abuse in the past 12 months
• Families, important people of participants in the study have concerns
• Live in the same household as a participant who has been randomly assigned
• Severe aphasia, physical disability, or any other factor that may prevent completion of neuropsychological testing
• Use of medications that may affect cognition, including sedatives, anxiolytics, hypnotics, nootropics, and cholinergic drugs; Refusing or not receiving cognitive training
• currently participating in another clinical trial.

Sponsors & Collaborators

• Fanfan Zheng: lead

Study Sites (1)

Xihuangcun Hospital

Beijing, 100144, China

Location

Related Publications (1)

• Pan Y, Ji M, Liang J, Ma J, Zhang W, Liu Y, Dai Y, Gao D, Zhang Y, Xie W, Zheng F. Effects of COgNitive Training in Community-dwelling Older Adults at High Risk for demENTia (CONTENT): study protocol of two double-blind, randomised, placebo-controlled trials. BMJ Open. 2026 Feb 9;16(2):e095515. doi: 10.1136/bmjopen-2024-095515.

  PMID: 41663164 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 23, 2024
• First Posted: July 29, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)