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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
84
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.
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 .
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
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.
Time frame: baseline, 4, 12, 24 weeks
Learning
The Auditory Verbal Learning Test (minimum to maximum: 0-45) will be applied, and higher scores mean a better outcome for the scale.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: baseline and 24 weeks