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NCT Number: NCT07213362

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

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.

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Key information

Conditions

Mild Cognitive Disorder Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Computerized Cognitive Training

Device

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

Primary outcomes

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

    Time frame: Week 12 post-randomization

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

Secondary outcomes

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

    Time frame: Weeks 4, 12, and 24 post-randomization.

    Scores derived from this assessment scale range from 0 to 12. A higher score corresponds to worse mental health status.

  2. 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.

    Time frame: Weeks 4, 12, and 24 post-randomization.

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

    Time frame: at weeks 4, 12, and 24 post-randomization.

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

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

    Time frame: Weeks 4 and 24 post-randomization

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

Other outcomes

  1. Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: at weeks 4, 12, and 24 post-randomization.

Study contacts

Contact information is provided by the study sponsor or research team.

Haibo Wang

CONTACT

[email protected]

+8613521204583

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

Study on the Effect of Different Doses of Computerized Cognitive Training on Cognitive Function in Patients With Mild Cognitive Impairment: An Open-Label, Randomized, Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

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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