Mild Cognitive Disorder
Conditions
Brief summary
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.
Interventions
DEVICEComputerized Cognitive Training
Computerized Cognitive Training (30 minutes per session, 3 sessions per week, for a 12-week period)
Sponsors
Peking University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The improvement in cognitive function from baseline at week 12 post-randomization, assessed by the Montreal Cognitive Assessment (MoCA) total score. | Week 12 post-randomization | Scores derived from this assessment scale range from 0 to 30. A higher score corresponds to superior cognitive ability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
Other
| Measure | Time frame |
|---|---|
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | at weeks 4, 12, and 24 post-randomization. |
Contacts
Primary ContactHaibo Wang
Outcome results
None listed