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

NCT06094452 | Completed

• 1 other identifier: ChongqingMU9
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Learning

  baseline, 4, 12, 24 weeks

• Episodic Memory

  baseline, 4, 12, 24 weeks

• Attention

  baseline, 4, 12, 24 weeks

• Executive Function

  baseline, 4, 12, 24 weeks

• Visuospatial Function

  baseline, 4, 12, 24 weeks

Study Arms (2)

Computerized Cognitive Training

EXPERIMENTAL

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.

Other: Computerized Cognitive Training

Treatment As Usual

ACTIVE COMPARATOR

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.

Other: Treatment As Usual

Interventions

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.

Computerized Cognitive Training

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 .

Treatment As Usual

Eligibility Criteria

• Age: 55 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Links

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

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Weihua Yu, Dr.

  Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Since it will not be possible to blind the participants because the experimental and control interventions have to be explained to them and their caregivers before randomization. The single blinding will be applied to researchers who conducted the measurements to minimize the potential assessor biases. Blinding will be also maintained for data management, outcome assessment, and data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 23, 2023
• Study Start: October 21, 2020
• Primary Completion: August 19, 2022
• Study Completion: August 19, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: Data can be requested at least 18 months after publication of the research articles.
• Access Criteria: With publication of research articles, de-identified data collected for the study, including individual participant data, can be made available to interested parties on reasonable request, and if in line with privacy regulations, with a proposal by sending an e-mail to Dr. Yang Lü.

Locations

CN (1)