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.
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.
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.
Parallel
Computerized Cognitive Training
DeviceComputerized Cognitive Training (30 minutes per session, 3 sessions per week, for a 12-week period)
Computerized Cognitive Training
DeviceComputerized Cognitive Training (45 minutes per session, 3 sessions per week, for a 12-week period)
Computerized Cognitive Training
DeviceComputerized Cognitive Training (60 minutes per session, 3 sessions per week, for a 12-week period)
Computerized Cognitive Training
DeviceComputerized Cognitive Training (30 minutes per session, 5 sessions per week, for a 12-week period)
Computerized Cognitive Training
DeviceComputerized Cognitive Training (45 minutes per session, 5 sessions per week, for a 12-week period)
Computerized Cognitive Training
DeviceComputerized Cognitive Training (60 minutes per session, 5 sessions per week, for a 12-week period)
6
Treatment groupsSee each treatment group below.
The improvement in cognitive function from baseline at week 12 post-randomization, assessed by the Montreal Cognitive Assessment (MoCA) total score.
Scores derived from this assessment scale range from 0 to 30. A higher score corresponds to superior cognitive ability.
Mental health status at weeks 4, 12, and 24 post-randomization, assessed using the Patient Health Questionnaire-4 (PHQ-4)
Scores derived from this assessment scale range from 0 to 12. A higher score corresponds to worse mental health status.
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.
Functional activities at weeks 4, 12, and 24 post-randomization，assessed based on the scores from the Functional Activity Questionnaire(FAQ)
Scores derived from this assessment scale range from 0 to 30. A higher score corresponds to superior functional activity ability.
Change from baseline in Montreal Cognitive Assessment (MoCA) scale scores at weeks 4 and 24 post-randomization.
Scores derived from this assessment scale range from 0 to 30. A higher score corresponds to superior cognitive ability.
Adverse Events (AEs) and Serious Adverse Events (SAEs)
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This trial is not recruiting at the moment. You can still explore other options:
