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

Alzheimer Disease Clinical Trial

Official title:

Effects of 24-week Computerized Cognitive Training on Microbiota-gut-brain Axis in Patients With Mild Cognitive Impairment and Mild Alzheimer's Disease: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06094452
• Other study ID #: ChongqingMU9
• Status: Completed
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: August 19, 2022

Study information

• Verified date: October 2023
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• Computerized Cognitive Training
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.
• 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 .

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	baseline, 4, 12, 24 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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 (a-diversity) of the bacteria on Genus, will be analyzed in R.	baseline and 24 weeks
Secondary	Beta-diversity of Gut Microbiome	After 16S rRNA high-throughput sequencing, the cluster analysis between different samples (ß-diversity) will be analyzed in R.	baseline and 24 weeks
Secondary	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

External Links

•   The trail has also been registered under chictr.org.cn (ChiCTR2100051362).