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

Official title

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

Overview

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).

Interventions

• 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.

Primary outcome measures

• Montreal Cognitive Assessment (MoCA) [Time frame: baseline; "post-intervention, 12weeks"]

Secondary outcome measures (9)

• Montreal Cognitive Assessment (MoCA) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up]
• the Trail Making Test (TMT) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up]
• the Digit Symbol Substitution Test (DSST) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up]
• the WHO-UCLA Auditory Verbal Learning Test(AVLT) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up]
• the Boston Naming Test (BNT) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up]
• Geriatric Depression Scale (GDS) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"]
• Generalized Anxiety Disorder-7 (GAD-7) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"]
• Pittsburgh sleep quality index (PSQI) [Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"]
• fasting blood glucose [Time frame: baseline; "post-intervention, 12 weeks"]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Prevention

Study locations

China · 1 center

• Xihuangcun Hospital — Beijing

Publications

• 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

Identifiers

NCT: NCT06524388 · CFH 2024-2G-4253

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗