Study on the Effect of Online Cognitive Training Doses on Cognitive Function in Individuals With Mild Cognitive Decline

NCT07213362 | Not Yet Recruiting DMC

• 1 other identifier: IRB00001052-25101
• Study Type: interventional
• Target: 234
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary questions that this clinical trial aims to answer are: To compare the differences in the efficacy of different doses of Computerized Cognitive Training (CCT) in improving cognitive function among patients with Mild Cognitive Impairment (MCI), and to explore the potential optimal intervention dose. To analyze the interaction between individual characteristics and the intervention dose of CCT. To compare the improvement in functional activity ability of MCI patients among different CCT intervention dose groups. To compare the symptoms of depression and anxiety among different CCT intervention dose groups. To evaluate the adherence to different doses of CCT intervention. Participants will: Receive CCT intervention at varying durations and frequencies over a 12-week period, and will be followed up for cognitive function, functional activity ability, etc., at weeks 4, 12, and 24.

Conditions

Mild Cognitive Disorder

Outcome Measures

Primary Outcomes (1)

• The improvement in cognitive function from baseline at week 12 post-randomization, assessed by the Montreal Cognitive Assessment (MoCA) total score.

  Scores derived from this assessment scale range from 0 to 30. A higher score corresponds to superior cognitive ability.

  Week 12 post-randomization

Secondary Outcomes (4)

• Mental health status at weeks 4, 12, and 24 post-randomization, assessed using the Patient Health Questionnaire-4 (PHQ-4)

  Weeks 4, 12, and 24 post-randomization.

• Cognitive performance in sub-domains at weeks 4, 12, and 24 post-randomization, assessed based on the cognitive index, which is calculated by the cognitive training platform using scores from the training process.

  Weeks 4, 12, and 24 post-randomization.

• Functional activities at weeks 4, 12, and 24 post-randomization，assessed based on the scores from the Functional Activity Questionnaire(FAQ)

  at weeks 4, 12, and 24 post-randomization.

• Change from baseline in Montreal Cognitive Assessment (MoCA) scale scores at weeks 4 and 24 post-randomization.

  Weeks 4 and 24 post-randomization

Other Outcomes (1)

• Adverse Events (AEs) and Serious Adverse Events (SAEs)

  at weeks 4, 12, and 24 post-randomization.

Study Arms (6)

Group 1: 30 min/session × 3 sessions/week

ACTIVE COMPARATOR

CCT Training, 30 minutes per session, 3 times a week, for a total of 12 weeks

Device: Computerized Cognitive Training

Group 2: 45 min/session × 5 sessions/week

ACTIVE COMPARATOR

CCT Training, 45 minutes per session, 3 times a week, for a total of 12 weeks

Device: Computerized Cognitive Training

Group 3: 60 min/session × 5 sessions/week

ACTIVE COMPARATOR

CCT Training, 60 minutes per session, 3 times a week, for a total of 12 weeks

Device: Computerized Cognitive Training

Group 4: 30 min/session × 5 sessions/week

ACTIVE COMPARATOR

CCT Training, 30 minutes per session, 5 times a week, for a total of 12 weeks

Device: Computerized Cognitive Training

Group 5: 45 min/session × 5 sessions/week

ACTIVE COMPARATOR

CCT Training, 45 minutes per session, 5 times a week, for a total of 12 weeks

Device: Computerized Cognitive Training

Group 6: 60 min/session × 5 sessions/week

ACTIVE COMPARATOR

CCT Training, 60 minutes per session, 5 times a week, for a total of 12 weeks

Device: Computerized Cognitive Training

Interventions

Computerized Cognitive Training DEVICE

Computerized Cognitive Training (30 minutes per session, 3 sessions per week, for a 12-week period)

Group 1: 30 min/session × 3 sessions/week

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 60 years.
• Self-reported cognitive decline, confirmed by an informant.
• Montreal Cognitive Assessment (MoCA) score of 19-25, adjusted for years of education (+1 point for 12 years or less).
• Ability to complete activities of daily living independently.
• Possesses basic communication skills and is able to cooperate with the study procedures.
• Voluntarily agrees to participate in the study and signs the informed consent form.

You may not qualify if:

• Presence of underlying neurological diseases that may impair cognitive function, including but not limited to dementia syndrome, Parkinson's disease, epilepsy, and cerebrovascular disease.
• Presence of severe or unstable organic diseases such as cancer, hydrocephalus, history of central nervous system tumors, or acute brain injury/infection.
• Diagnosis of severe mental illness such as major depressive disorder, schizophrenia, schizoaffective disorder, or bipolar disorder.
• Presence of severe visual or hearing impairment, or other physical conditions that may interfere with the completion of the study.
• Participation in any other clinical trial within the past 3 months.
• Having received transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), light therapy, or having taken medications that could significantly affect cognitive function (e.g., nootropics, psychoactive drugs, anticholinergic drugs, benzodiazepines) for any reason within the past 6 months.
• History of alcohol dependence or substance abuse.
• Consumption of alcohol or other substances that affect cognitive function, such as caffeine or cocaine, within 24 hours prior to the cognitive assessment.
• Any other conditions that the investigator deems unsuitable for participation in this study.

Sponsors & Collaborators

• Peking University: lead

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Haibo Wang

CONTACT

+8613521204583; wanghb_pucri@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 8, 2025
• Study Start: October 8, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE