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Completed

NCT Number: NCT06094452

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

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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 .

Primary outcomes

  1. Global Cognition

    Time frame: 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 outcomes

  1. Learning

    Time frame: 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.

  2. Episodic Memory

    Time frame: 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.

  3. Attention

    Time frame: 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.

  4. Executive Function

    Time frame: 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.

  5. Visuospatial Function

    Time frame: 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.

  6. Verbal Ability

    Time frame: 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.

  7. Verbal Frequency

    Time frame: 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.

  8. Neuropsychiatric Symptoms

    Time frame: 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.

  9. Depression

    Time frame: 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.

  10. Daily Living Function

    Time frame: 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.

  11. Severity of Cognitive Impairment

    Time frame: 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.

  12. Brain Functional Connectivity

    Time frame: 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.

  13. Alpha-diversity of Gut Microbiome

    Time frame: 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.

  14. Beta-diversity of Gut Microbiome

    Time frame: baseline and 24 weeks

    After 16S rRNA high-throughput sequencing, the cluster analysis between different samples (β-diversity) will be analyzed in R.

  15. Composition of Gut Microbiome

    Time frame: baseline and 24 weeks

    After 16S rRNA high-throughput sequencing, the compositional analysis of bacteria on genus will be analyzed in R.

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2023
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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