Effects of 24-week Computerized Cognitive Training in Patients With MCI and AD

Not Applicable

Completed

• Conditions: Alzheimer Disease; Mild Cognitive Impairment
• Interventions: Other: Computerized Cognitive Training; Other: Treatment As Usual

• Registration Number: NCT06094452
• Lead Sponsor: Chongqing Medical University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2020-10-21
• Primary Completion: 2022-08-19
• Study Completion: 2022-08-19
• Status Verified: 2023-10
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-19
• Last Update Submitted: 2023-10-19
• Study First Posted: 2023-10-23
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

Inclusion Criteria

• between 55 and 90 years of age;
• a Clinical Dementia Rating (CDR) score of 0.5 or 1;
• at least three months of stable doses if receiving antidementia medication or mood-stabilizing medication for mild AD participants;
• primary school education and above;
• accompanied by a consistent caregiver (at least 5 days/week);
• informed consent.

Exclusion Criteria

• factors that might preclude completion of assessments;
• severe psychiatric illness and the use of antidepressants;
• any condition that would preclude completion of training and follow-up tests;
• other disorders that would affect cognition.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computerized Cognitive Training	Computerized Cognitive Training	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.
Treatment As Usual	Treatment As Usual	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.

Primary Outcome Measures

Name	Time	Method
Global Cognition	baseline, 4, 12, 24 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Learning	baseline, 4, 12, 24 weeks	The Auditory Verbal Learning Test (minimum to maximum: 0-45) will be applied, and higher scores mean a better outcome for the scale.
Episodic Memory	baseline, 4, 12, 24 weeks	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.
Depression	baseline, 4, 12, 24 weeks	The 30-Geriatric Depression Scale (minimum to maximum: 0-30) will be used, and higher scores mean a worse outcome for the scale.
Brain Functional Connectivity	baseline and 24 weeks	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.
Beta-diversity of Gut Microbiome	baseline and 24 weeks	After 16S rRNA high-throughput sequencing, the cluster analysis between different samples (β-diversity) will be analyzed in R.
Visuospatial Function	baseline, 4, 12, 24 weeks	The Clock Drawing Test (minimum to maximum: 0-15) will be applied, and higher scores mean a better outcome for the scale.
Verbal Frequency	baseline, 4, 12, 24 weeks	The Verbal Frequency Test (minimum: 0, no maximum) will also be applied, and higher scores mean a better outcome for the scale.
Daily Living Function	baseline, 4, 12, 24 weeks	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.
Severity of Cognitive Impairment	baseline, 4, 12, 24 weeks	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.
Attention	baseline, 4, 12, 24 weeks	The Trail Making Test (minimum to maximum: 0-24) will be applied, and higher scores mean a better outcome for the scale.
Verbal Ability	baseline, 4, 12, 24 weeks	The Boston Naming Test (minimum to maximum: 0-30) will be applied, and higher scores mean a better outcome for the scale.
Executive Function	baseline, 4, 12, 24 weeks	The Digital Span Test (minimum to maximum: 0-10) will also be applied, and higher scores mean a better outcome for the scale.
Neuropsychiatric Symptoms	baseline, 4, 12, 24 weeks	The Neuropsychiatric Inventory (minimum to maximum: 0-144) will be used, and higher scores mean a worse outcome for the scale.
Alpha-diversity of Gut Microbiome	baseline and 24 weeks	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.
Composition of Gut Microbiome	baseline and 24 weeks	After 16S rRNA high-throughput sequencing, the compositional analysis of bacteria on genus will be analyzed in R.

Trial Locations

Locations (1)

The First Affiliated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China