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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: 30 min/session × 3 sessions/week | Active Comparator | CCT Training, 30 minutes per session, 3 times a week, for a total of 12 weeks |
|
| Group 2: 45 min/session × 5 sessions/week | Active Comparator | CCT Training, 45 minutes per session, 3 times a week, for a total of 12 weeks |
|
| Group 3: 60 min/session × 5 sessions/week | Active Comparator | CCT Training, 60 minutes per session, 3 times a week, for a total of 12 weeks |
|
| Group 4: 30 min/session × 5 sessions/week | Active Comparator | CCT Training, 30 minutes per session, 5 times a week, for a total of 12 weeks |
|
| Group 5: 45 min/session × 5 sessions/week | Active Comparator | CCT Training, 45 minutes per session, 5 times a week, for a total of 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Cognitive Training | Device | Computerized Cognitive Training (30 minutes per session, 3 sessions per week, for a 12-week period) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 12 post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | at weeks 4, 12, and 24 post-randomization. |
Inclusion Criteria:
Exclusion Criteria:
Any other conditions that the investigator deems unsuitable for participation in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haibo Wang | Contact | +8613521204583 | wanghb_pucri@bjmu.edu.cn |
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all IPD that underlie results in a publication
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| Group 6: 60 min/session × 5 sessions/week |
| Active Comparator |
CCT Training, 60 minutes per session, 5 times a week, for a total of 12 weeks |
|
| Computerized Cognitive Training | Device | Computerized Cognitive Training (45 minutes per session, 3 sessions per week, for a 12-week period) |
|
| Computerized Cognitive Training | Device | Computerized Cognitive Training (60 minutes per session, 3 sessions per week, for a 12-week period) |
|
| Computerized Cognitive Training | Device | Computerized Cognitive Training (30 minutes per session, 5 sessions per week, for a 12-week period) |
|
| Computerized Cognitive Training | Device | Computerized Cognitive Training (45 minutes per session, 5 sessions per week, for a 12-week period) |
|
| Computerized Cognitive Training | Device | Computerized Cognitive Training (60 minutes per session, 5 sessions per week, for a 12-week period) |
|
| 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) | Scores derived from this assessment scale range from 0 to 30. A higher score corresponds to superior functional activity ability. | 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. | Scores derived from this assessment scale range from 0 to 30. A higher score corresponds to superior cognitive ability. | Weeks 4 and 24 post-randomization |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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