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NCT Number: NCT07788209

Scaffolding in AI-Empowered Cognitive Training Improves Outcomes in Cognitive Impairment

This retrospective study aimed to validate and compare two individualized, closed-loop, AI-driven computerized cognitive training programs with a conventional non-AI training program in a real-world clinical setting. Using objective tablet-recorded data from patients' prior treatment, participants were categorized into three groups according to the training recommendation strategy they actually received. Changes in global cognitive function and specific cognitive domains after 8 weeks of training were compared across groups to evaluate the association between different training strategies and cognitive outcomes.

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This study is active but is not currently recruiting participants.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuanwu Hospital, Capital Medical University

Beijing, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age ≥ 45 years;
  • a Montreal Cognitive Assessment (MoCA) score between 10 and 25;
  • were able to communicate in Mandarin.

Exclusion criteria

  • no completion of at least 8 weeks of training;
  • no engagement in training for ≥ 60 minutes per week;
  • diagnosis of depression or other psychiatric disorders;
  • diagnosis of systemic diseases, such as hepatic or renal dysfunction, endocrine disorders, or vitamin deficiencies.

Treatment and study plan

AI-Based Adaptive CCT Optimized for Cognitive Improvement

Behavioral

Participants received a multi-domain computerized cognitive training program delivered on a tablet. The program used an AI-based adaptive, closed-loop recommendation strategy to individualize training tasks and difficulty levels, with the goal of maximizing cognitive improvement over the training period.

AI-Based Adaptive CCT Optimized for Cognitive Performance

Behavioral

Participants received a multi-domain computerized cognitive training program delivered on a tablet. The program used an AI-based adaptive, closed-loop recommendation strategy to individualize training tasks and difficulty levels, with the goal of maximizing cognitive task performance during training.

Conventional Non-AI CCT

Behavioral

Participants received a conventional computerized cognitive training program delivered on a tablet. Training tasks were randomly selected within the cognitive domains corresponding to participants' symptomatic impairments and difficulty levels were fixed.

Primary outcomes

  1. Change in general cognitive ability from baseline (week 1) to week 8

    Time frame: From baseline (week 1) to week 8

    The general cognitive ability was assessed by the Cognitive Index, calculated from task performance scores. The CCT platforms recorded the Cognitive Index in real time on a daily basis. Weekly Cognitive Index values were computed as the mean of the daily scores recorded over each 7-day period. The change in Cognitive Index from baseline to week 8 is reported.

Secondary outcomes

  1. Changes in domain-specific cognitive ability from baseline (week 1) to week 8 across seven cognitive subdomains

    Time frame: From baseline (week 1) to week 8

    Seven cognitive subdomains include perception, attention, memory, language, executive function, thinking, and emotion. Domain-specific cognitive ability was calculated by averaging the scores of all tasks targeting the same cognitive domain. The change from baseline to week 8 is reported.

Other outcomes

  1. Maximum attainable improvement in general cognitive ability

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the Cognitive Index. Training dose was defined as the cumulative number of completed training tasks up to each training day. The outcome measure was the model-estimated asymptote parameter, representing the maximum attainable improvement in the Cognitive Index with increasing training dose. Higher values indicate greater maximum attainable improvement.

  2. Rate of improvement in general cognitive ability

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the Cognitive Index. Training dose was defined as the cumulative number of completed training tasks up to each training day. The outcome measure was the model-estimated learning-rate parameter, representing the rate at which the Cognitive Index improved with increasing training dose. Higher values indicate a faster rate of improvement.

  3. Maximum attainable improvement in perception

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the perception subdomain index. The outcome measure was the model-estimated asymptote parameter, representing the maximum attainable improvement in perception with increasing training dose. Higher values indicate greater maximum attainable improvement.

  4. Rate of improvement in perception

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the perception subdomain index. The outcome measure was the model-estimated learning-rate parameter, representing the rate at which performance in the perception subdomain improved with increasing training dose. Higher values indicate a faster rate of improvement.

  5. Maximum attainable improvement in attention

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the attention subdomain index. The outcome measure was the model-estimated asymptote parameter, representing the maximum attainable improvement in attention with increasing training dose. Higher values indicate greater maximum attainable improvement.

  6. Rate of improvement in attention

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the attention subdomain index. The outcome measure was the model-estimated learning-rate parameter, representing the rate at which performance in the attention subdomain improved with increasing training dose. Higher values indicate a faster rate of improvement.

  7. Maximum attainable improvement in memory

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the memory subdomain index. The outcome measure was the model-estimated asymptote parameter, representing the maximum attainable improvement in memory with increasing training dose. Higher values indicate greater maximum attainable improvement.

  8. Rate of improvement in memory

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the memory subdomain index. The outcome measure was the model-estimated learning-rate parameter, representing the rate at which performance in the memory subdomain improved with increasing training dose. Higher values indicate a faster rate of improvement.

  9. Maximum attainable improvement in language

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the language subdomain index. The outcome measure was the model-estimated asymptote parameter, representing the maximum attainable improvement in language with increasing training dose. Higher values indicate greater maximum attainable improvement.

  10. Rate of improvement in language

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the language subdomain index. The outcome measure was the model-estimated learning-rate parameter, representing the rate at which performance in the language subdomain improved with increasing training dose. Higher values indicate a faster rate of improvement.

  11. Maximum attainable improvement in executive function

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the executive function subdomain index. The outcome measure was the model-estimated asymptote parameter, representing the maximum attainable improvement in executive function with increasing training dose. Higher values indicate greater maximum attainable improvement.

  12. Rate of improvement in executive function

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the executive function subdomain index. The outcome measure was the model-estimated learning-rate parameter, representing the rate at which performance in the executive function subdomain improved with increasing training dose. Higher values indicate a faster rate of improvement.

  13. Maximum attainable improvement in thinking

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the thinking subdomain index. The outcome measure was the model-estimated asymptote parameter, representing the maximum attainable improvement in thinking with increasing training dose. Higher values indicate greater maximum attainable improvement.

  14. Rate of improvement in thinking

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the thinking subdomain index. The outcome measure was the model-estimated learning-rate parameter, representing the rate at which performance in the thinking subdomain improved with increasing training dose. Higher values indicate a faster rate of improvement.

  15. Maximum attainable improvement in emotion

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the emotion subdomain index. The outcome measure was the model-estimated asymptote parameter, representing the maximum attainable improvement in emotion with increasing training dose. Higher values indicate greater maximum attainable improvement.

  16. Rate of improvement in emotion

    Time frame: From baseline (week 1) to week 8

    A dose-response function was fitted to model the relationship between cumulative training dose and change from baseline in the emotion subdomain index. The outcome measure was the model-estimated learning-rate parameter, representing the rate at which performance in the emotion subdomain improved with increasing training dose. Higher values indicate a faster rate of improvement.

Sponsors and collaborators

Lead sponsor

Xuanwu Hospital, Beijing

Other

Registry information

Official study title

Scaffolding in AI-Empowered Cognitive Training Improves Outcomes in Cognitive Impairment: A Real-world Retrospective Cohort Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 26, 2026
Registry last updated
Aug 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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