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

Peking University

Status

Not yet enrolling

Conditions

Mild Cognitive Disorder

Treatments

Device: Computerized Cognitive Training

Study type

Interventional

Funder types

Other

Identifiers

NCT07213362

IRB00001052-25101

Details and patient eligibility

About

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.

Enrollment

234 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

234 participants in 6 patient groups

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

Active Comparator group

Description:

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

Treatment:

Device: Computerized Cognitive Training

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

Active Comparator group

Description:

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

Treatment:

Device: Computerized Cognitive Training

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

Active Comparator group

Description:

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

Treatment:

Device: Computerized Cognitive Training

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

Active Comparator group

Description:

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

Treatment:

Device: Computerized Cognitive Training

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

Active Comparator group

Description:

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

Treatment:

Device: Computerized Cognitive Training

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

Active Comparator group

Description:

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

Treatment:

Device: Computerized Cognitive Training

Trial contacts and locations

Central trial contact

Haibo Wang

Data sourced from clinicaltrials.gov

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