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

Chongqing Medical University

Status: Completed

Conditions: Alzheimer Disease; Mild Cognitive Impairment

Treatments: Other: Treatment As Usual; Other: Computerized Cognitive Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06094452

ChongqingMU9

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Computerized Cognitive Training

Experimental group

Description:

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:

Other: Computerized Cognitive Training

Treatment As Usual

Active Comparator group

Description:

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.

Treatment:

Other: Treatment As Usual