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

Официальное название

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

Обзор

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).

Вмешательства

• Устройство 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.
• Устройство placebo cognitive training
  Participants received cognitive training tasks of fixed difficulty.

Первичные конечные точки

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

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Xihuangcun Hospital — Пекин

Публикации

• 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

Идентификаторы

NCT: NCT06524388 · CFH 2024-2G-4253

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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