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This study aims to testify multi-domain effects of computerized cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease through multi-dimensional evaluation.
This study aimed to elucidate the neural process enhancement and remodulation in gut microbes resulting from older adults with MCI and mild AD in a randomized controlled trial of a 24-week computerized cognitive training (CCT) program.
After recruitment and baseline assessments, pairs of participants with MCI and mild AD would be randomly allocated into the corresponding subgroup. Participants in CCT group will receive a computerized multidomain cognitive training program (www.66nao.com) and will be required to complete at least 30 minutes of training per day (3 cycle of 5 2-min tasks), 5 days a week for 24 weeks. Adherence to the intervention will be supervised by an independent researcher. The number of training days and training hours per day will be recorded. Patients in control group received treatment as usual (TAU) for 24 weeks. The neuropsychological measures will be performed at baseline, follow-up at 4 weeks, 12 weeks, and 24 weeks; functional Near-Infrared Spectroscopy (fNIRS) data and fecal samples will collected at baseline and 24 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerized Cognitive Training | Experimental | Adaptive computerized cognitive training program (www.66nao.com) and the intensity is at least 30 minutes of training per day (3 cycle of 5 2-min tasks), 5 days a week for 24 weeks. |
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| Treatment As Usual | Active Comparator | Patients in control group will receive TAU for 24 weeks, which includes (1) regular medication management from the Memory Clinic, if applicable; (2) basic health education at each follow-up (face to face) and twice per month on the internet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Cognitive Training | Other | Participants in intervention group will receive a multidomain, adaptive computerized cognitive training program (www.66nao.com) and will be required to complete at least 30 minutes of training per day (3 cycle of 5 2-min tasks), 5 days a week for 24 weeks. Multidomain coverage paradigms include working memory, calculation, processing speed, attention, executive function, and short-term and long-term memory. |
| Measure | Description | Time Frame |
|---|---|---|
| Global Cognition | The Alzheimer's Disease Assessment Scale- cognitive subscale (11 items) will be used to evaluate global cognition and served as the primary outcome measure. The minimum and maximum values are 0 and 70 respectively, and higher scores mean a worse outcome. | baseline, 4, 12, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Learning | The Auditory Verbal Learning Test (minimum to maximum: 0-45) will be applied, and higher scores mean a better outcome for the scale. | baseline, 4, 12, 24 weeks |
| Episodic Memory | The Free and Cued Selective Reminding Test (minimum to maximum: 0-48) will be applied, and higher scores mean a better outcome for the scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Weihua Yu, Dr. | Chongqing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | 400016 | China |
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| Label | URL |
|---|---|
| The trail has also been registered under chictr.org.cn (ChiCTR2100051362). | View source |
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With publication of research articles, de-identified data collected for the study, including individual participant data, can be made available to interested parties on reasonable request, and if in line with privacy regulations. Data can be requested at least 18 months after publication of the research articles, with a proposal by sending an e-mail to Dr. Yang Lü.
Data can be requested at least 18 months after publication of the research articles.
With publication of research articles, de-identified data collected for the study, including individual participant data, can be made available to interested parties on reasonable request, and if in line with privacy regulations, with a proposal by sending an e-mail to Dr. Yang Lü.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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After recruitment and baseline assessments, pairs of participants with MCI and mild AD will be randomly allocated into either the CCT group and the control group. Participants in CCT group will receive a multidomain adaptive computerized cognitive training program (www.66nao.com) for 24 weeks. Patients in control group will receive treatment as usual (TAU) for 24 weeks.
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Since it will not be possible to blind the participants because the experimental and control interventions have to be explained to them and their caregivers before randomization. The single blinding will be applied to researchers who conducted the measurements to minimize the potential assessor biases. Blinding will be also maintained for data management, outcome assessment, and data analysis.
|
| Treatment As Usual | Other | Patients in control group will receive TAU for 24 weeks, which includes (1) regular medication management from the Memory Clinic, if applicable; (2) basic health education at each follow-up (face to face) and twice per month on the internet . |
|
| baseline, 4, 12, 24 weeks |
| Attention | The Trail Making Test (minimum to maximum: 0-24) will be applied, and higher scores mean a better outcome for the scale. | baseline, 4, 12, 24 weeks |
| Executive Function | The Digital Span Test (minimum to maximum: 0-10) will also be applied, and higher scores mean a better outcome for the scale. | baseline, 4, 12, 24 weeks |
| Visuospatial Function | The Clock Drawing Test (minimum to maximum: 0-15) will be applied, and higher scores mean a better outcome for the scale. | baseline, 4, 12, 24 weeks |
| Verbal Ability | The Boston Naming Test (minimum to maximum: 0-30) will be applied, and higher scores mean a better outcome for the scale. | baseline, 4, 12, 24 weeks |
| Verbal Frequency | The Verbal Frequency Test (minimum: 0, no maximum) will also be applied, and higher scores mean a better outcome for the scale. | baseline, 4, 12, 24 weeks |
| Neuropsychiatric Symptoms | The Neuropsychiatric Inventory (minimum to maximum: 0-144) will be used, and higher scores mean a worse outcome for the scale. | baseline, 4, 12, 24 weeks |
| Depression | The 30-Geriatric Depression Scale (minimum to maximum: 0-30) will be used, and higher scores mean a worse outcome for the scale. | baseline, 4, 12, 24 weeks |
| Daily Living Function | The Instrumental Activities of Daily Living scale (minimum to maximum: 0-31) will be used, and higher scores mean a worse outcome for this scale. | baseline, 4, 12, 24 weeks |
| Severity of Cognitive Impairment | The Clinical Dementia Rating scale (sum of boxes, minimum to maximum: 0-18) will be used, and higher scores mean a worse outcome for this scale. | baseline, 4, 12, 24 weeks |
| Brain Functional Connectivity | The regions of interests (ROIs) are selected as the Brodmann Area (BA) 9 and 46 (overlapping the dorsolateral prefrontal cortex, DLPFC), left Brodmann Area 6 (overlapping pre-Motor and Supplementary Motor Cortex, PM-SMC), and right Brodmann Area 45 (overlapping pars triangularis Broca's area). For each resting-state dataset of fNIRS, functional connectivity (FC) will be analyzed by Spearman's correlation between the time series of each ROI-to-ROI pair. | baseline and 24 weeks |
| Alpha-diversity of Gut Microbiome | Fecal samples will be collected from patients in standard 300 mL sterilin tubes and frozen immediately at -80°C. Patients will be asked to produce the first-morning sample for consistency and to avoid alcohol the previous 24 h. After 16S rRNA high-throughput sequencing, the diversity analysis of species under a sample (α-diversity) of the bacteria on Genus, will be analyzed in R. | baseline and 24 weeks |
| Beta-diversity of Gut Microbiome | After 16S rRNA high-throughput sequencing, the cluster analysis between different samples (β-diversity) will be analyzed in R. | baseline and 24 weeks |
| Composition of Gut Microbiome | After 16S rRNA high-throughput sequencing, the compositional analysis of bacteria on genus will be analyzed in R. | baseline and 24 weeks |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |