- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07753382
Effects of Adaptive Difficulty Computerized Cognitive Training on Cognitive Function Improvement in Older Adults With Mild Cognitive Impairment
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ziyi Zhang
- Número de teléfono: +8613314010321
- Correo electrónico: zhangziyi202058@163.com
Ubicaciones de estudio
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Liaoning
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Shenyang, Liaoning, Porcelana, 110000
- Ren'ai Changwan Community Elderly Care Service Station, Dadong
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Contacto:
- Yu Liu, PhD
- Número de teléfono: +8618193218315
- Correo electrónico: 2968500699@qq.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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 <23.
- Able to use a mobile application (mini program) to perform cognitive training.
Exclusion Criteria:
- 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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: High-Frequency Maintenance Training
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.
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Participants receive adaptive computerized cognitive training delivered through the Heling Brain Planet WeChat mini- program.
The intervention consists of individualized cognitive exercises targeting multiple cognitive domains, including attention, memory, executive function, language, visuospatial ability, perceptual-motor function, and social cognition.
The training difficulty is automatically adjusted according to each participant's performance to provide personalized cognitive stimulation.
During the initial intervention phase, all participants complete 30-minute training sessions three times per week for 3 months.
After the initial intervention, participants choose to continue training receive maintenance adaptive computerized cognitive training.
Participants receive adaptive computerized cognitive training delivered through the Heling Brain Planet WeChat mini- program.
The intervention consists of individualized cognitive exercises targeting multiple cognitive domains, including attention, memory, executive function, language, visuospatial ability, perceptual-motor function, and social cognition.
The training difficulty is automatically adjusted according to each participant's performance to provide personalized cognitive stimulation.
During the initial intervention phase, all participants complete 30-minute training sessions three times per week for 3 months.
After the initial intervention, participants not to continue discontinue the intervention and undergo follow-up assessments only.
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Otro: Training Discontinuation Group
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.
|
Participants receive adaptive computerized cognitive training delivered through the Heling Brain Planet WeChat mini- program.
The intervention consists of individualized cognitive exercises targeting multiple cognitive domains, including attention, memory, executive function, language, visuospatial ability, perceptual-motor function, and social cognition.
The training difficulty is automatically adjusted according to each participant's performance to provide personalized cognitive stimulation.
During the initial intervention phase, all participants complete 30-minute training sessions three times per week for 3 months.
After the initial intervention, participants choose to continue training receive maintenance adaptive computerized cognitive training.
Participants receive adaptive computerized cognitive training delivered through the Heling Brain Planet WeChat mini- program.
The intervention consists of individualized cognitive exercises targeting multiple cognitive domains, including attention, memory, executive function, language, visuospatial ability, perceptual-motor function, and social cognition.
The training difficulty is automatically adjusted according to each participant's performance to provide personalized cognitive stimulation.
During the initial intervention phase, all participants complete 30-minute training sessions three times per week for 3 months.
After the initial intervention, participants not to continue discontinue the intervention and undergo follow-up assessments only.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in global cognitive function assessed by the Montreal Cognitive Assessment (MoCA)
Periodo de tiempo: Baseline, Month 3, Month 4, and Month 6
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Baseline, Month 3, Month 4, and Month 6
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in cognitive function assessed by the Mini-Mental State Examination (MMSE)
Periodo de tiempo: Baseline, Month 3, Month 4, and Month 6
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Baseline, Month 3, Month 4, and Month 6
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Change in language function assessed by the Boston Naming Test (BNT)
Periodo de tiempo: Baseline, Month 3, Month 4, and Month 6
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Baseline, Month 3, Month 4, and Month 6
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Change in attention assessed by the Trail Making Test Part A (TMT-A)
Periodo de tiempo: Baseline, Month 3, Month 4, and Month 6
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Baseline, Month 3, Month 4, and Month 6
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Change in executive function assessed by the Stroop Color-Word Test
Periodo de tiempo: Baseline, Month 3, Month 4, and Month 6
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Baseline, Month 3, Month 4, and Month 6
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Change in visuospatial function assessed by the Clock Drawing Test (CDT)
Periodo de tiempo: Baseline, Month 3, Month 4, and Month 6
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Baseline, Month 3, Month 4, and Month 6
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Change in activities of daily living assessed by the Activities of Daily Living (ADL) scale
Periodo de tiempo: Baseline, Month 3, Month 4, and Month 6
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Baseline, Month 3, Month 4, and Month 6
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
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Términos relacionados con este estudio
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Otros números de identificación del estudio
- China Medical University (china medical university and hospital)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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