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临床试验/NCT07753382
NCT07753382尚未招募不适用

Effects of Adaptive Difficulty Computerized Cognitive Training on Cognitive Function Improvement in Older Adults With Mild Cognitive Impairment

China Medical University, China1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年8月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
试验地点
1
主要终点
Change in global cognitive function assessed by the Montreal Cognitive Assessment (MoCA)

研究概览

简要总结

This study aims to evaluate the effectiveness of adaptive computerized cognitive training (CCT) in improving cognitive function among community-dwelling older adults with mild cognitive impairment (MCI) and to compare the maintenance effects of different training frequencies after the initial intervention. A quasi-experimental study will be conducted in three communities in Shenyang, Liaoning Province, China. All participants will receive a 12-week adaptive CCT program. Participants will be assigned to either a high-frequency maintenance training group or a training discontinuation group. Cognitive assessments will be performed at baseline, immediately after the intervention, and during follow-up. The primary outcome is global cognitive function, while secondary outcomes include memory, attention, executive function, language, visuospatial ability, and activities of daily living. The findings of this study are expected to provide evidence for optimizing computerized cognitive training programs and long-term management strategies for older adults with MCI in community settings.

详细描述

With the rapid aging of the global population, mild cognitive impairment (MCI) has become a critical stage for dementia prevention and early intervention. Cognitive training is recognized as one of the most effective non-pharmacological interventions for individuals with MCI. Among various approaches, adaptive computerized cognitive training (CCT) can dynamically adjust task difficulty according to an individual's performance, thereby improving training personalization, engagement, and adherence. However, evidence regarding the optimal maintenance training frequency and the long-term sustainability of cognitive benefits remains limited.

This study adopts a quasi-experimental design and will recruit community-dwelling adults aged 60 years and older with MCI from three communities in Shenyang, Liaoning Province, China. All participants will complete a 12-week adaptive computerized cognitive training program using the Heling Brain Planet WeChat mini-program, with training sessions lasting 30 minutes, three times per week. After the initial intervention, participants will be assigned to either a high-frequency maintenance training group, which will continue training three times per week, or a training discontinuation group, which will receive routine community health management only. Follow-up cognitive assessments will be conducted after the intervention and during the follow-up period.

The primary outcome will be global cognitive function assessed by the Montreal Cognitive Assessment (MoCA). Secondary outcomes will include memory (Auditory Verbal Learning Test, AVLT), attention (Trail Making Test Part A, TMT-A), executive function (Stroop Color-Word Test), language (Boston Naming Test, BNT), visuospatial ability (Clock Drawing Test, CDT), and activities of daily living (ADL). The effects of different maintenance training frequencies on cognitive improvement and the persistence of intervention benefits will be compared.

This study is expected to evaluate the effectiveness of adaptive computerized cognitive training for improving cognitive function in community-dwelling older adults with MCI and to determine whether continued maintenance training can prolong cognitive benefits. The findings will provide evidence for optimizing community-based digital cognitive training programs and developing sustainable intervention strategies for the long-term management of older adults with MCI.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >= 60 years;
  • Planning to reside in the community for at least 12 months, with no intention to move into a nursing home;
  • No clinical diagnosis of dementia;
  • Meeting the diagnostic criteria for mild cognitive impairment (MCI) as defined in the Chinese Expert Consensus on the Diagnosis and Treatment of Alzheimer's Disease-Related Mild Cognitive Impairment (2021), The cut-off scores for the Beijing version of the Montreal Cognitive Assessment (MoCA) were adjusted for educational level: <=13 for junior high school or below, <=19 for high school, and <=24 for college education or above. Mini-Mental State Examination (MMSE) score >= 24; Activities of Daily Living (ADL) score <
  • Able to use a mobile application (mini program) to perform cognitive training.

排除标准

  • Individuals unable to complete the questionnaires due to hearing or visual impairments;
  • Those with other organic diseases of the central nervous system, such as brain tumors, epilepsy, or Parkinson's disease;
  • Those diagnosed with severe mental disorders, such as schizophrenia, depression, or anxiety disorders.

研究组 & 干预措施

High-Frequency Maintenance Training

Experimental

Participants will receive adaptive computerized cognitive training using the Heling Brain Planet WeChat mini-program. During the initial intervention phase, participants will complete training sessions three times per week for 30 minutes per session over 12 weeks. After the initial intervention, participants will continue maintenance training three times per week until the end of the follow-up period. The training program automatically adjusts task difficulty according to individual performance and includes exercises targeting attention, memory, executive function, language, visuospatial ability, and other cognitive domains.

干预措施: Adaptive Computerized Cognitive Training (Behavioral)

Training Discontinuation Group

Other

Participants will receive the same 12-week adaptive computerized cognitive training program during the initial intervention phase. After completing the initial intervention, no further computerized cognitive training will be provided. Participants will continue to receive routine community health management and will complete follow-up cognitive assessments according to the study schedule.

干预措施: Adaptive Computerized Cognitive Training (Behavioral)

结局指标

主要结局

Change in global cognitive function assessed by the Montreal Cognitive Assessment (MoCA)

时间窗: Baseline, Month 3, Month 4, and Month 6

次要结局

  • Change in executive function assessed by the Stroop Color-Word Test(Baseline, Month 3, Month 4, and Month 6)
  • Change in visuospatial function assessed by the Clock Drawing Test (CDT)(Baseline, Month 3, Month 4, and Month 6)
  • Change in cognitive function assessed by the Mini-Mental State Examination (MMSE)(Baseline, Month 3, Month 4, and Month 6)
  • Change in language function assessed by the Boston Naming Test (BNT)(Baseline, Month 3, Month 4, and Month 6)
  • Change in attention assessed by the Trail Making Test Part A (TMT-A)(Baseline, Month 3, Month 4, and Month 6)
  • Change in activities of daily living assessed by the Activities of Daily Living (ADL) scale(Baseline, Month 3, Month 4, and Month 6)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhang Ziyi

Graduate Student Researcher

China Medical University, China

研究点 (1)

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