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

Official 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

Overview

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.

Interventions

• Device Computerized Cognitive Training
  Computerized Cognitive Training (30 minutes per session, 3 sessions per week, for a 12-week period)
• Device Computerized Cognitive Training
  Computerized Cognitive Training (45 minutes per session, 3 sessions per week, for a 12-week period)
• Device Computerized Cognitive Training
  Computerized Cognitive Training (60 minutes per session, 3 sessions per week, for a 12-week period)
• Device Computerized Cognitive Training
  Computerized Cognitive Training (30 minutes per session, 5 sessions per week, for a 12-week period)
• Device Computerized Cognitive Training
  Computerized Cognitive Training (45 minutes per session, 5 sessions per week, for a 12-week period)
• Device Computerized Cognitive Training
  Computerized Cognitive Training (60 minutes per session, 5 sessions per week, for a 12-week period)

Primary outcome measures

• 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]

Secondary outcome measures (4)

• 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.]
• 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.]
• 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.]
• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07213362 · IRB00001052-25101

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗