Clinical trial NCT06094452: Effects of 24-week Computerized Cognitive Training in Patients With MCI and AD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Keywords: computerized cognitive training
functional near-infrared spectroscopy
mild cognitive impairment
Alzheimer's disease
brain-gut-microbiota axis
gut microbiota
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 84
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Global Cognition
timeFrame: baseline, 4, 12, 24 weeks
Secondary outcomes:
measure: Learning
timeFrame: baseline, 4, 12, 24 weeks
measure: Episodic Memory
timeFrame: baseline, 4, 12, 24 weeks
measure: Attention
timeFrame: baseline, 4, 12, 24 weeks
measure: Executive Function
timeFrame: baseline, 4, 12, 24 weeks
measure: Visuospatial Function
timeFrame: baseline, 4, 12, 24 weeks
measure: Verbal Ability
timeFrame: baseline, 4, 12, 24 weeks
measure: Verbal Frequency
timeFrame: baseline, 4, 12, 24 weeks
measure: Neuropsychiatric Symptoms
timeFrame: baseline, 4, 12, 24 weeks
measure: Depression
timeFrame: baseline, 4, 12, 24 weeks
measure: Daily Living Function
timeFrame: baseline, 4, 12, 24 weeks
measure: Severity of Cognitive Impairment
timeFrame: baseline, 4, 12, 24 weeks
measure: Brain Functional Connectivity
timeFrame: baseline and 24 weeks
measure: Alpha-diversity of Gut Microbiome
timeFrame: baseline and 24 weeks
measure: Beta-diversity of Gut Microbiome
timeFrame: baseline and 24 weeks
measure: Composition of Gut Microbiome
timeFrame: baseline and 24 weeks
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Chongqing Medical University
name: Weihua Yu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: