Mild Cognitive DisorderNCT07213362
Study on the Effect of Online Cognitive Training Doses on Cognitive Function in Individuals With Mild Cognitive Decline
A study testing Computerized Cognitive Training in people with Mild Cognitive Disorder, run by Peking University.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mild Cognitive Disorder
- What is being tested?
- Computerized Cognitive Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read more
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
- Being tested
- Computerized Cognitive Training
- Medical subject headings
- Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive TrainingDevice
Computerized Cognitive Training (30 minutes per session, 3 sessions per week, for a 12-week period)
Computerized Cognitive TrainingDevice
Computerized Cognitive Training (45 minutes per session, 3 sessions per week, for a 12-week period)
Computerized Cognitive TrainingDevice
Computerized Cognitive Training (60 minutes per session, 3 sessions per week, for a 12-week period)
Computerized Cognitive TrainingDevice
Computerized Cognitive Training (30 minutes per session, 5 sessions per week, for a 12-week period)
Computerized Cognitive TrainingDevice
Computerized Cognitive Training (45 minutes per session, 5 sessions per week, for a 12-week period)
Computerized Cognitive TrainingDevice
Computerized Cognitive Training (60 minutes per session, 5 sessions per week, for a 12-week period)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: 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 Receives: Device: Computerized Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Scores derived from this assessment scale range from 0 to 12. A higher score corresponds to worse mental health status.
Measured: 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.
Measured: 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)
Scores derived from this assessment scale range from 0 to 30. A higher score corresponds to superior functional activity ability.
Measured: 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.
Scores derived from this assessment scale range from 0 to 30. A higher score corresponds to superior cognitive ability.
Measured: Weeks 4 and 24 post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start8 Oct 2025 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive DisorderStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haibo Wang, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213362
- Sponsor's protocol ID
- IRB00001052-25101
- Status last verified
- Oct 2025
- First submitted
- 16 Sep 2025
- Last updated
- 8 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07213362
- Acronym / sponsor ID
- IRB00001052-25101
- Conditions
- Mild Cognitive Disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 8 Oct 2025 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1: 30 min/session × 3 sessions/week | Active comparator | Device: Computerized Cognitive TrainingCCT Training, 30 minutes per session, 3 times a week, for a total of 12 weeks |
| Group 2: 45 min/session × 5 sessions/week | Active comparator | Device: Computerized Cognitive TrainingCCT Training, 45 minutes per session, 3 times a week, for a total of 12 weeks |
| Group 3: 60 min/session × 5 sessions/week | Active comparator | Device: Computerized Cognitive TrainingCCT Training, 60 minutes per session, 3 times a week, for a total of 12 weeks |
| Group 4: 30 min/session × 5 sessions/week | Active comparator | Device: Computerized Cognitive TrainingCCT Training, 30 minutes per session, 5 times a week, for a total of 12 weeks |
| Group 5: 45 min/session × 5 sessions/week | Active comparator | Device: Computerized Cognitive TrainingCCT Training, 45 minutes per session, 5 times a week, for a total of 12 weeks |
| Group 6: 60 min/session × 5 sessions/week | Active comparator | Device: Computerized Cognitive TrainingCCT Training, 60 minutes per session, 5 times a week, for a total of 12 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computerized Cognitive TrainingComputerized Cognitive Training (30 minutes per session, 3 sessions per week, for a 12-week period) | Device | Group 1: 30 min/session × 3 sessions/week |
| Computerized Cognitive TrainingComputerized Cognitive Training (45 minutes per session, 3 sessions per week, for a 12-week period) | Device | Group 2: 45 min/session × 5 sessions/week |
| Computerized Cognitive TrainingComputerized Cognitive Training (60 minutes per session, 3 sessions per week, for a 12-week period) | Device | Group 3: 60 min/session × 5 sessions/week |
| Computerized Cognitive TrainingComputerized Cognitive Training (30 minutes per session, 5 sessions per week, for a 12-week period) | Device | Group 4: 30 min/session × 5 sessions/week |
| Computerized Cognitive TrainingComputerized Cognitive Training (45 minutes per session, 5 sessions per week, for a 12-week period) | Device | Group 5: 45 min/session × 5 sessions/week |
| Computerized Cognitive TrainingComputerized Cognitive Training (60 minutes per session, 5 sessions per week, for a 12-week period) | Device | Group 6: 60 min/session × 5 sessions/week |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Training in people with Mild Cognitive Disorder, run by Peking University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haibo Wang (+8613521204583, wanghb_pucri@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.