Study on the Effect of Different Doses of Computerized Cognitive Training on Cognitive Function in Patients With Mild Cognitive Impairment: An Open-Label, Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 234
- 主要终点
- The improvement in cognitive function from baseline at week 12 post-randomization, assessed by the Montreal Cognitive Assessment (MoCA) total score.
研究概览
简要总结
The primary questions that this clinical trial aims to answer are:
To compare the differences in the efficacy of different doses of Computerized Cognitive Training (CCT) in improving cognitive function among patients with Mild Cognitive Impairment (MCI), and to explore the potential optimal intervention dose.
To analyze the interaction between individual characteristics and the intervention dose of CCT.
To compare the improvement in functional activity ability of MCI patients among different CCT intervention dose groups.
To compare the symptoms of depression and anxiety among different CCT intervention dose groups.
To evaluate the adherence to different doses of CCT intervention.
Participants will:
Receive CCT intervention at varying durations and frequencies over a 12-week period, and will be followed up for cognitive function, functional activity ability, etc., at weeks 4, 12, and 24.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •Age ≥ 60 years.
- •Self-reported cognitive decline, confirmed by an informant.
- •Montreal Cognitive Assessment (MoCA) score of 19-25, adjusted for years of education (+1 point for 12 years or less).
- •Ability to complete activities of daily living independently.
- •Possesses basic communication skills and is able to cooperate with the study procedures.
- •Voluntarily agrees to participate in the study and signs the informed consent form.
排除标准
- •Presence of underlying neurological diseases that may impair cognitive function, including but not limited to dementia syndrome, Parkinson's disease, epilepsy, and cerebrovascular disease.
- •Presence of severe or unstable organic diseases such as cancer, hydrocephalus, history of central nervous system tumors, or acute brain injury/infection.
- •Diagnosis of severe mental illness such as major depressive disorder, schizophrenia, schizoaffective disorder, or bipolar disorder.
- •Presence of severe visual or hearing impairment, or other physical conditions that may interfere with the completion of the study.
- •Participation in any other clinical trial within the past 3 months.
- •Having received transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), light therapy, or having taken medications that could significantly affect cognitive function (e.g., nootropics, psychoactive drugs, anticholinergic drugs, benzodiazepines) for any reason within the past 6 months.
- •History of alcohol dependence or substance abuse.
- •Consumption of alcohol or other substances that affect cognitive function, such as caffeine or cocaine, within 24 hours prior to the cognitive assessment.
- •Any other conditions that the investigator deems unsuitable for participation in this study.
结局指标
主要结局
The improvement in cognitive function from baseline at week 12 post-randomization, assessed by the Montreal Cognitive Assessment (MoCA) total score.
时间窗: Week 12 post-randomization
Scores derived from this assessment scale range from 0 to 30. A higher score corresponds to superior cognitive ability.
次要结局
- Mental health status at weeks 4, 12, and 24 post-randomization, assessed using the Patient Health Questionnaire-4 (PHQ-4)(Weeks 4, 12, and 24 post-randomization.)
- Cognitive performance in sub-domains at weeks 4, 12, and 24 post-randomization, assessed based on the cognitive index, which is calculated by the cognitive training platform using scores from the training process.(Weeks 4, 12, and 24 post-randomization.)
- Functional activities at weeks 4, 12, and 24 post-randomization，assessed based on the scores from the Functional Activity Questionnaire(FAQ)(at weeks 4, 12, and 24 post-randomization.)
- Change from baseline in Montreal Cognitive Assessment (MoCA) scale scores at weeks 4 and 24 post-randomization.(Weeks 4 and 24 post-randomization)
研究者
Haibo Wang
Research Fellow
Peking University