Cognitive Impairment, MildNCT05922319
Effects of Training Dose on Computerized Cognitive Training in Patients With Cognitive Impairment
An observational study of Cognitive Impairment, Mild and Dementia, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
The goal of this observational study is to explore the optimal dose of computerized cognitive training in patients with cognitive impairment. The main questions it aims to answer are: Is there an optimal dose of computerized cognitive training for patients with cognitive impairment? Is the optimal dose different in… Read more about this study
- Who is it for?
- Ages 40 to 100 years
- Conditions the study is for
- Cognitive Impairment, Mild, Dementia
- What is being tested?
- Computerized cognitive training with different training doses
- How many people
- 21,845 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The participants are outpatients who took a reported computerized cognitive training program at home in 2017-2022 in China.
Who may be able to join
- Patients with cognitive impairment.
- Patients who took computerized cognitive training in 2017-2022.
- age ≥ 40 years
- Training duration ≥ 2 weeks
Who cannot join
- with moderate to severe dementia, cancer, unstable systemic diseases, or psychiatric diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Training Dose on Computerized Cognitive Training in People With Cognitive Impairment: A Large-population Retrospective Study
The goal of this observational study is to explore the optimal dose of computerized cognitive training in patients with cognitive impairment. The main questions it aims to answer are:
- Is there an optimal dose of computerized cognitive training for patients with cognitive impairment?
- Is the optimal dose different in patients in different age populations? Participants enrolled in the study took a reported computerized cognitive training program and the training data were analyzed for exploring the optimal dose.
Read more
The researchers will compare the different dose groups to see if there is an optimal dose for the highest improvement in cognitive abilities.
The researchers will additionally compare two age groups (aged younger than 60y or aged 60y and older) to see if the optimal doses in the two groups are different.
Read the detailed description
Background: Computerized Cognitive Training (CCT) is a form of digital therapeutics that uses computerized cognitive tasks to train patients with cognitive impairment caused by various neurological or psychiatric diseases. CCT has been shown to slow the progression of cognitive impairment in early-stage dementia, particularly in working memory. However, there is a lack of research on the optimal training dose for people with cognitive impairment. Previous meta-analyses have explored the types, delivery methods, and training dose of cognitive training in healthy older adults and those with dementia risk factors, but not in those with cognitive impairment.
Objectives: The study aimed to explore the dose-response relationship of CCT and estimate the optimal daily and weekly dose for people with cognitive impairment.
Participants and methods: the study is a retrospective cohort study and will enroll 21845 patients with cognitive impairment. The exposures in the study are different doses of cognitive training in a week and the outcome is the improvement in cognitive abilities in a week. The weeks with the same training dose of different patients will be classified into one group of exposure. The mixed effects model will be used to estimate the optimal dose.
- Conditions
- Cognitive Impairment, Mild, Dementia
- Being tested
- Computerized cognitive training with different training doses
- Medical subject headings
- Cognitive Dysfunction, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive training with different training dosesOther
The training dose was defined as training frequency (number of training days per week) and average training duration per training day. The daily dose was divided into 13 categories with an interval of 5 minutes and the training frequency has 7 categories according to the number of training days per week.
| Study group | Role | What they receive |
|---|---|---|
| Patients with cognitive impairment taking computerized cognitive training | The exposures and outcomes were measured repeatedly during the training process for each patient. The outcomes were compared to assess the effect of different exposures (computerized cognitive training with different doses). A mixed effects model was built to solve the random effects of patients. Receives: Other: Computerized cognitive training with different training doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive abilities between the adjacent weeks
Cognitive ability is measured on the final day of training each week. The cognitive ability throughout a week is calculated based on the overall performance of cognitive training. The overall training performance is an averaged performance integrating the performance of all cognitive training tasks targeting different cognitive domains (e.g., thinking, memory, perception, attention, executive function). The performance of a certain training task is standardized according to normative scores from 0 to 100. Change in cognitive abilities is quantified as the disparity of cognitive abilities between the adjacent weeks (the measurement will be executed everyweek repeatedly).
Measured: At the end of each week through the study completion (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start1 Jul 2023
- Primary completion30 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Impairment, MildStudies 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
- 21,845 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Tang, M.D., Ph.D., Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05922319
- Sponsor's protocol ID
- 2023027
- Status last verified
- Jun 2023
- First submitted
- 2 Apr 2023
- Last updated
- 21 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Training Dose on Computerized Cognitive Training in People With Cognitive Impairment: A Large-population Retrospective Study
- ClinicalTrials.gov ID
- NCT05922319
- Acronym / sponsor ID
- 2023027
- Conditions
- Cognitive Impairment, Mild, Dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21,845 participants (actual)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 28 Jun 2023 (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 goal of this observational study is to explore the optimal dose of computerized cognitive training in patients with cognitive impairment. The main questions it aims to answer are:
- Is there an optimal dose of computerized cognitive training for patients with cognitive impairment?
- Is the optimal dose different in patients in different age populations? Participants enrolled in the study took a reported computerized cognitive training program and the training data were analyzed for exploring the optimal dose.
The researchers will compare the different dose groups to see if there is an optimal dose for the highest improvement in cognitive abilities.
The researchers will additionally compare two age groups (aged younger than 60y or aged 60y and older) to see if the optimal doses in the two groups are different.
Detailed description
Background: Computerized Cognitive Training (CCT) is a form of digital therapeutics that uses computerized cognitive tasks to train patients with cognitive impairment caused by various neurological or psychiatric diseases. CCT has been shown to slow the progression of cognitive impairment in early-stage dementia, particularly in working memory. However, there is a lack of research on the optimal training dose for people with cognitive impairment. Previous meta-analyses have explored the types, delivery methods, and training dose of cognitive training in healthy older adults and those with dementia risk factors, but not in those with cognitive impairment.
Objectives: The study aimed to explore the dose-response relationship of CCT and estimate the optimal daily and weekly dose for people with cognitive impairment.
Participants and methods: the study is a retrospective cohort study and will enroll 21845 patients with cognitive impairment. The exposures in the study are different doses of cognitive training in a week and the outcome is the improvement in cognitive abilities in a week. The weeks with the same training dose of different patients will be classified into one group of exposure. The mixed effects model will be used to estimate the optimal dose.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with cognitive impairment taking computerized cognitive training | – | Other: Computerized cognitive training with different training dosesThe exposures and outcomes were measured repeatedly during the training process for each patient. The outcomes were compared to assess the effect of different exposures (computerized cognitive training with different doses). A mixed effects model was built to solve the random effects of patients. |
Who may qualify
- Ages
- 40 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants are outpatients who took a reported computerized cognitive training program at home in 2017-2022 in China.
Key inclusion criteria (4 listed)
- Patients with cognitive impairment.
- Patients who took computerized cognitive training in 2017-2022.
- age ≥ 40 years
- Training duration ≥ 2 weeks
Key exclusion criteria (1 listed)
- with moderate to severe dementia, cancer, unstable systemic diseases, or psychiatric diseases
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 training with different training dosesThe training dose was defined as training frequency (number of training days per week) and average training duration per training day. The daily dose was divided into 13 categories with an interval of 5 minutes and the training frequency has 7 categories according to the number of training days per week. | Other | Patients with cognitive impairment taking computerized cognitive training |
Primary outcome
Change in cognitive abilities between the adjacent weeks
Time frame: At the end of each week through the study completion (up to 5 years)
Cognitive ability is measured on the final day of training each week. The cognitive ability throughout a week is calculated based on the overall performance of cognitive training. The overall training performance is an averaged performance integrating the performance of all cognitive training tasks targeting different cognitive domains (e.g., thinking, memory, perception, attention, executive function). The performance of a certain training task is standardized according to normative scores from 0 to 100. Change in cognitive abilities is quantified as the disparity of cognitive abilities between the adjacent weeks (the measurement will be executed everyweek repeatedly).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
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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.
Yi Tang, M.D., Ph.D. principal investigator
Xuanwu Hospital, Beijing
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, Mild and Dementia, 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 4 inclusion and 1 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: finished, as of the sponsor's last update on 21 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 cognitive abilities between the adjacent weeks (time frame: At the end of each week through the study completion (up to 5 years)). 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 21 May 2024.