Cognitive ImpairmentNCT07788209
Scaffolding in AI-Empowered Cognitive Training Improves Outcomes in Cognitive Impairment
An observational study of Cognitive Impairment, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- AI-Based Adaptive CCT Optimized for Cognitive Improvement, AI-Based Adaptive CCT Optimized for Cognitive Performance and Conventional Non-AI CCT
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 516 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2026to 25 Aug 2027
- Phase
- Observational
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population included patients with cognitive impairment who had received an 8-week tablet-based computerized cognitive training program at Xuanwu Hospital between October 2021 and May 2024. Participants were categorized into three groups according to the training recommendation strategy they actually received.
Who may be able to join
- age ≥ 45 years;
- a Montreal Cognitive Assessment (MoCA) score between 10 and 25;
- were able to communicate in Mandarin.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Scaffolding in AI-Empowered Cognitive Training Improves Outcomes in Cognitive Impairment: A Real-world Retrospective Cohort Study
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.
- Conditions
- Cognitive Impairment
- Being tested
- AI-Based Adaptive CCT Optimized for Cognitive Improvement, AI-Based Adaptive CCT Optimized for Cognitive Performance, Conventional Non-AI CCT
- Keywords
- Computerized cognitive training, Artificial intelligence, Scaffolding theory, Cognitive impairment, Personalization
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Based Adaptive CCT Optimized for Cognitive ImprovementBehavioural
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 PerformanceBehavioural
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 CCTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Most-Improvement oriented CCT (AIMI) | An AI-based CCT program that based on compensatory principles and prioritized tasks expected to produce the greatest improvement relative to prior performance. Training data indicated that participants self-administered the CCT at home using a tablet or computer over an 8-week period, with sessions lasting at least 20 minutes and occurring approximately three times per week on average. Receives: Behavioral: AI-Based Adaptive CCT Optimized for Cognitive Improvement | |
| Best-Performance oriented CCT (AIBP) | An AI-based program that based on the scaffolding theory and prioritized tasks associated with the highest task performance score. Training data indicated that participants self-administered the CCT at home using a tablet or computer over an 8-week period, with sessions lasting at least 20 minutes and occurring approximately three times per week on average. Receives: Behavioral: AI-Based Adaptive CCT Optimized for Cognitive Performance | |
| Non-AI randomly CCT | A conventional non-AI program in which training tasks were randomly selected within the cognitive domains corresponding to participants' symptomatic impairments. Training data indicated that participants self-administered the CCT at home using a tablet or computer over an 8-week period, with sessions lasting at least 20 minutes and occurring approximately three times per week on average. Receives: Behavioral: Conventional Non-AI CCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in general cognitive ability 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.
Measured: From baseline (week 1) to week 8
Secondary outcomes (1)
Changes in domain-specific cognitive ability from baseline (week 1) to week 8 across seven cognitive subdomains
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.
Measured: From baseline (week 1) to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start15 Aug 2026
- Primary completion25 Aug 2027 (estimated)
- Study completion25 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 516 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07788209
- Sponsor's protocol ID
- 2026229
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu L, Wang H, Xing Y, Zhang Z, Zhang Q, Dong M, Ma Z, Cai L, Wang X, Tang Y. Dose-response relationship between computerized cognitive training and cognitive improvement. NPJ Digit Med. 2024 Aug 15;7(1):214. doi: 10.1038/s41746-024-01210-9.
PubMed 39147783Liu LY, Xing Y, Zhang ZH, Zhang QG, Dong M, Wang H, Cai L, Wang X, Tang Y. Validation of a Computerized Cognitive Training Tool to Assess Cognitive Impairment and Enable Differentiation Between Mild Cognitive Impairment and Dementia. J Alzheimers Dis. 2023;96(1):93-101. doi: 10.3233/JAD-230416.
PubMed 37742644Tang Y, Xing Y, Zhu Z, He Y, Li F, Yang J, Liu Q, Li F, Teipel SJ, Zhao G, Jia J. The effects of 7-week cognitive training in patients with vascular cognitive impairment, no dementia (the Cog-VACCINE study): A randomized controlled trial. Alzheimers Dement. 2019 May;15(5):605-614. doi: 10.1016/j.jalz.2019.01.009. Epub 2019 Mar 17.
PubMed 30894299
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaffolding in AI-Empowered Cognitive Training Improves Outcomes in Cognitive Impairment: A Real-world Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07788209
- Acronym / sponsor ID
- 2026229
- Conditions
- Cognitive Impairment
- Keywords
- Computerized cognitive training, Artificial intelligence, Scaffolding theory, Cognitive impairment, Personalization
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 516 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 15 Aug 2026 (actual)
- Primary completion
- 25 Aug 2027 (estimated)
- Study completion
- 25 Aug 2027 (estimated)
- First posted
- 26 Aug 2026 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Most-Improvement oriented CCT (AIMI) | – | Behavioral: AI-Based Adaptive CCT Optimized for Cognitive ImprovementAn AI-based CCT program that based on compensatory principles and prioritized tasks expected to produce the greatest improvement relative to prior performance. Training data indicated that participants self-administered the CCT at home using a tablet or computer over an 8-week period, with sessions lasting at least 20 minutes and occurring approximately three times per week on average. |
| Best-Performance oriented CCT (AIBP) | – | Behavioral: AI-Based Adaptive CCT Optimized for Cognitive PerformanceAn AI-based program that based on the scaffolding theory and prioritized tasks associated with the highest task performance score. Training data indicated that participants self-administered the CCT at home using a tablet or computer over an 8-week period, with sessions lasting at least 20 minutes and occurring approximately three times per week on average. |
| Non-AI randomly CCT | – | Behavioral: Conventional Non-AI CCTA conventional non-AI program in which training tasks were randomly selected within the cognitive domains corresponding to participants' symptomatic impairments. Training data indicated that participants self-administered the CCT at home using a tablet or computer over an 8-week period, with sessions lasting at least 20 minutes and occurring approximately three times per week on average. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population included patients with cognitive impairment who had received an 8-week tablet-based computerized cognitive training program at Xuanwu Hospital between October 2021 and May 2024. Participants were categorized into three groups according to the training recommendation strategy they actually received.
Key inclusion criteria (3 listed)
- age ≥ 45 years;
- a Montreal Cognitive Assessment (MoCA) score between 10 and 25;
- were able to communicate in Mandarin.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| AI-Based Adaptive CCT Optimized for Cognitive ImprovementParticipants 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. | Behavioural | Most-Improvement oriented CCT (AIMI) |
| AI-Based Adaptive CCT Optimized for Cognitive PerformanceParticipants 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. | Behavioural | Best-Performance oriented CCT (AIBP) |
| Conventional Non-AI CCTParticipants 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. | Behavioural | Non-AI randomly CCT |
Primary outcome
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.
1 secondary outcome
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
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 26 Aug 2026.
- Background: PubMed 39147783Liu L, Wang H, Xing Y, Zhang Z, Zhang Q, Dong M, Ma Z, Cai L, Wang X, Tang Y. Dose-response relationship between computerized cognitive training and cognitive improvement. NPJ Digit Med. 2024 Aug 15;7(1):214. doi: 10.1038/s41746-024-01210-9.
- Background: PubMed 37742644Liu LY, Xing Y, Zhang ZH, Zhang QG, Dong M, Wang H, Cai L, Wang X, Tang Y. Validation of a Computerized Cognitive Training Tool to Assess Cognitive Impairment and Enable Differentiation Between Mild Cognitive Impairment and Dementia. J Alzheimers Dis. 2023;96(1):93-101. doi: 10.3233/JAD-230416.
- Background: PubMed 30894299Tang Y, Xing Y, Zhu Z, He Y, Li F, Yang J, Liu Q, Li F, Teipel SJ, Zhao G, Jia J. The effects of 7-week cognitive training in patients with vascular cognitive impairment, no dementia (the Cog-VACCINE study): A randomized controlled trial. Alzheimers Dement. 2019 May;15(5):605-614. doi: 10.1016/j.jalz.2019.01.009. Epub 2019 Mar 17.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, run by Xuanwu Hospital, Beijing at 1 site in China.
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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in general cognitive ability from baseline (week 1) to week 8 (time frame: From baseline (week 1) to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07788209, which also lists 3 linked publications.
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 26 Aug 2026.