CognitionNCT06524388
Adaptive Cognitive Training on Cognitive Function in Elderly Diabetes Patients in the Community
A study testing adaptive cognitive training in people with Cognition and Diabetes Mellitus, Type 2, run by Fanfan Zheng at 1 site in China.
Trial summary
Objective A growing body of evidence supports diabetes as a risk factor for cognitive decline. Diabetes is significantly associated with accelerated cognitive decline, poorer cognitive function, and mild cognitive impairment and dementia. Cognitive training is an effective intervention to improve cognitive function. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cognition, Diabetes Mellitus, Type 2, Aging
- What is being tested?
- adaptive cognitive training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2024to Jun 2027
- 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
- with a clear diagnosis of diabetes (according to ICD-10 or DSM-criteria), fasting blood glucose≥6.1mmol/L, maintaining the original diabetes treatment strategy
- age ≥60 years old
- literate and able to use smart phone or tablet computer skillfully, with CAIDE dementia risk score >9, but without a diagnosis of dementia (ICD-10 or DSM-dementia diagnostic criteria)
- have lived in the target community for at least 6 months and continue to live in the original community for the next 12 months
Who cannot join
- Stroke or brain surgery in the previous 12 months
- Alcohol or drug abuse in the past 12 months
- Families, important people of participants in the study have concerns
- Live in the same household as a participant who has been randomly assigned
- Severe aphasia, physical disability, or any other factor that may prevent completion of neuropsychological testing
- Use of medications that may affect cognition, including sedatives, anxiolytics, hypnotics, nootropics, and cholinergic drugs; Refusing or not receiving cognitive training
- currently participating in another clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Effects of COgNitive Training in Community-dwelling Older Adults at High Risk for demENTia and With Diabetes (CONTENT-Diabetes): a Randomized, Placebo-controlled Trial
Objective A growing body of evidence supports diabetes as a risk factor for cognitive decline. Diabetes is significantly associated with accelerated cognitive decline, poorer cognitive function, and mild cognitive impairment and dementia. Cognitive training is an effective intervention to improve cognitive function. However, the current cognitive training does not fully consider the different areas and degrees of cognitive function impairment of older adults. This study aims to evaluate the effect of adaptive cognitive training on cognitive function of older adults with hypertension in the community.
Participants Age 60 years or older, diagnosis of diabetes, fasting blood glucose≥6.1mmol/L and cognitive function assessment showed no dementia.
Design The study was designed as a double-blind randomized controlled trial. 120 diabetes participants without dementia aged 60 years or older in Shijingshan, Beijing and Haidian, Beijing were included. Participants will be randomized to adaptive cognitive training (intervention group) and placebo cognitive training (control group) at a ratio of 1:1. Both training will be delivered by using PADs with the same appearance. The interventions will last for 6 months and follow up to 12 months, and both groups will be followed up on the same time schedules for all outcome measurements. The primary outcome is changes in MoCA scores from baseline to post-intervention, 6 months. The current trial has been reviewed by the Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College (approval number: 2024-162).
- Conditions
- Cognition, Diabetes Mellitus, Type 2, Aging
- Being tested
- adaptive cognitive training, placebo cognitive training
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adaptive cognitive trainingDevice
The intervention was computerized, multi-domain, adaptive cognitive training. Training areas include processing speed, attention, perception, long-term memory, working memory, computation, executive control, reasoning, and problem-solving. Embedded in the Adaptive Cognitive training application is an adaptive algorithm that will help provide each participant with a cognitive training task at the right level of difficulty based on their profile and real-time performance.
placebo cognitive trainingDevice
Participants received cognitive training tasks of fixed difficulty.
| Study group | Role | What they receive |
|---|---|---|
| adaptive cognitive training | Experimental | The intervention lasted for 12 weeks. Participants will revieve 30 minutes of training per day, at least five days per week. In each task, once a high accuracy (e.g. >80%) is achieved, the task is automatically upgraded to the next difficulty level. Receives: Device: adaptive cognitive training |
| placebo cognitive training | Placebo comparator | The intervention lasted for 12 weeks. Participants will revieve 30 minutes of training per day, at least five days per week. The tasks will be set to a fixed level of difficulty. Receives: Device: placebo cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
MoCA has been widely used in the cognitive function assessment of middle-aged and elderly people in China, including executive function, memory, orientation, computation, conceptual thinking, visual perception, language, and attention. The MoCA scale scores ranged from 0 to 30, and the lower the score, the worse the cognitive function.
Measured: baseline; "post-intervention, 12weeks"
Secondary outcomes (9)
Montreal Cognitive Assessment (MoCA)
MoCA has been widely used in the cognitive function assessment of middle-aged and elderly people in China, including executive function, memory, orientation, computation, conceptual thinking, visual perception, language, and attention. The MoCA scale scores ranged from 0 to 30, and the lower the score, the worse the cognitive function.
Measured: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
the Trail Making Test (TMT)
The TMT assesses cognitive processing speed and executive function. The TMT consists of two parts, A and B, and is one of the most widely used neuropsychological assessment tools. The TMT-A requires the subject to connect disorderly arranged numbers from 1 to 25 in order. Investigator used a modified version that included numbers in both square and circle figures and required participants to alternate the two figures when connecting the numbers in order. The score index was the time spent on TMT-A and TMT-B and the amount of interference (time spent on TMT-B - time spent on TMT-A).
Measured: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
the Digit Symbol Substitution Test (DSST)
DSST has 1-9 numbers and corresponding symbols. Subjects were required to correctly fill in the symbols under the numbers according to the corresponding relationship between numbers and symbols in the 90s content. One point was calculated for every one completed within 90 seconds, and the higher the score, the better the cognitive function.
Measured: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
the WHO-UCLA Auditory Verbal Learning Test(AVLT)
AVLT consisted of 15 words, which were read aloud at a rate of one word in 2 seconds while the subject listened. After reading aloud, the subjects were asked to recall the words as much as possible for 90 seconds, and the recall did not have to be in the order of reading aloud. During the recall process, the examiner recorded the correct words and their number, inserted and repeated words. The above reading and immediate recall were repeated 5 times. The total score of AVLT recall from 1 to 5 passes was the total score of immediate recall. Delayed recall and cued recall were also performed, and distractor exclusion recall was performed.
Measured: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
the Boston Naming Test (BNT)
There were 30 pictures in the BNT, and subjects were required to name the pictures, each of which was scored on a scale of 0-2. Two points were given for complete correctness, one point for semantic errors, and zero points for other situations. The sum of the scores of all objects gives a total score, with a maximum score of 60.
Measured: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
Geriatric Depression Scale (GDS)
GDS describes the participant's depressive symptoms in the past week on a scale of 0 to 15, with higher scores indicating more severe depressive symptoms.
Measured: baseline; 6 week-intervention; "post-intervention, 12 weeks"
Generalized Anxiety Disorder-7 (GAD-7)
GAD-7 assesses the anxiety of the participants in the past two weeks, with a total of 7 items. The total score ranges from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: baseline; 6 week-intervention; "post-intervention, 12 weeks"
Pittsburgh sleep quality index (PSQI)
PSQI assesses the subjective sleep quality of participants in the past month. The total score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Measured: baseline; 6 week-intervention; "post-intervention, 12 weeks"
fasting blood glucose
Fasting blood glucose will be obtained by blood samples,which will be collected by nurses from community hospitals in a fasted state (at least 8 hours without food or water).
Measured: baseline; "post-intervention, 12 weeks"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start29 Oct 2024
- Primary completionSep 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fanfan Zheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Fanfan Zheng, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06524388
- Sponsor's protocol ID
- CFH 2024-2G-4253
- Status last verified
- Feb 2025
- First submitted
- 23 Jul 2024
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Trial outcome data and essential baseline characteristics data are available upon request. Researchers interested in accessing the trial dataset should contact the corresponding author with details of their proposed research use. Data access will be provided subject to review and approval of the research protocol and execution of a data use agreement.
Publications
Pan Y, Ji M, Liang J, Ma J, Zhang W, Liu Y, Dai Y, Gao D, Zhang Y, Xie W, Zheng F. Effects of COgNitive Training in Community-dwelling Older Adults at High Risk for demENTia (CONTENT): study protocol of two double-blind, randomised, placebo-controlled trials. BMJ Open. 2026 Feb 9;16(2):e095515. doi: 10.1136/bmjopen-2024-095515.
PubMed 41663164
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of COgNitive Training in Community-dwelling Older Adults at High Risk for demENTia and With Diabetes (CONTENT-Diabetes): a Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06524388
- Acronym / sponsor ID
- CFH 2024-2G-4253
- Conditions
- Cognition, Diabetes Mellitus, Type 2, Aging
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Fanfan ZhengUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 Jul 2024 (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.
Objective A growing body of evidence supports diabetes as a risk factor for cognitive decline. Diabetes is significantly associated with accelerated cognitive decline, poorer cognitive function, and mild cognitive impairment and dementia. Cognitive training is an effective intervention to improve cognitive function. However, the current cognitive training does not fully consider the different areas and degrees of cognitive function impairment of older adults. This study aims to evaluate the effect of adaptive cognitive training on cognitive function of older adults with hypertension in the community.
Participants Age 60 years or older, diagnosis of diabetes, fasting blood glucose≥6.1mmol/L and cognitive function assessment showed no dementia.
Design The study was designed as a double-blind randomized controlled trial. 120 diabetes participants without dementia aged 60 years or older in Shijingshan, Beijing and Haidian, Beijing were included. Participants will be randomized to adaptive cognitive training (intervention group) and placebo cognitive training (control group) at a ratio of 1:1. Both training will be delivered by using PADs with the same appearance. The interventions will last for 6 months and follow up to 12 months, and both groups will be followed up on the same time schedules for all outcome measurements. The primary outcome is changes in MoCA scores from baseline to post-intervention, 6 months. The current trial has been reviewed by the Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences \& Peking Union Medical College (approval number: 2024-162).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adaptive cognitive training | Experimental | Device: adaptive cognitive trainingThe intervention lasted for 12 weeks. Participants will revieve 30 minutes of training per day, at least five days per week. In each task, once a high accuracy (e.g. >80%) is achieved, the task is automatically upgraded to the next difficulty level. |
| placebo cognitive training | Placebo comparator | Device: placebo cognitive trainingThe intervention lasted for 12 weeks. Participants will revieve 30 minutes of training per day, at least five days per week. The tasks will be set to a fixed level of difficulty. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- with a clear diagnosis of diabetes (according to ICD-10 or DSM-criteria), fasting blood glucose≥6.1mmol/L, maintaining the original diabetes treatment strategy
- age ≥60 years old
- literate and able to use smart phone or tablet computer skillfully, with CAIDE dementia risk score >9, but without a diagnosis of dementia (ICD-10 or DSM-dementia diagnostic criteria)
- have lived in the target community for at least 6 months and continue to live in the original community for the next 12 months
Key exclusion criteria (7 listed)
- Stroke or brain surgery in the previous 12 months
- Alcohol or drug abuse in the past 12 months
- Families, important people of participants in the study have concerns
- Live in the same household as a participant who has been randomly assigned
- Severe aphasia, physical disability, or any other factor that may prevent completion of neuropsychological testing
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 |
|---|---|---|
| adaptive cognitive trainingThe intervention was computerized, multi-domain, adaptive cognitive training. Training areas include processing speed, attention, perception, long-term memory, working memory, computation, executive control, reasoning, and problem-solving. Embedded in the Adaptive Cognitive training application is an adaptive algorithm that will help provide each participant with a cognitive training task at the right level of difficulty based on their profile and real-time performance. | Device | adaptive cognitive training |
| placebo cognitive trainingParticipants received cognitive training tasks of fixed difficulty. | Device | placebo cognitive training |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: baseline; "post-intervention, 12weeks"
MoCA has been widely used in the cognitive function assessment of middle-aged and elderly people in China, including executive function, memory, orientation, computation, conceptual thinking, visual perception, language, and attention. The MoCA scale scores ranged from 0 to 30, and the lower the score, the worse the cognitive function.
9 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
the Trail Making Test (TMT)
Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
the Digit Symbol Substitution Test (DSST)
Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
the WHO-UCLA Auditory Verbal Learning Test(AVLT)
Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
the Boston Naming Test (BNT)
Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"; 24 weeks follow-up
Geriatric Depression Scale (GDS)
Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"
Generalized Anxiety Disorder-7 (GAD-7)
Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"
Pittsburgh sleep quality index (PSQI)
Time frame: baseline; 6 week-intervention; "post-intervention, 12 weeks"
fasting blood glucose
Time frame: baseline; "post-intervention, 12 weeks"
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 4 Dec 2025.
- Derived from this study: PubMed 41663164Pan Y, Ji M, Liang J, Ma J, Zhang W, Liu Y, Dai Y, Gao D, Zhang Y, Xie W, Zheng F. Effects of COgNitive Training in Community-dwelling Older Adults at High Risk for demENTia (CONTENT): study protocol of two double-blind, randomised, placebo-controlled trials. BMJ Open. 2026 Feb 9;16(2):e095515. doi: 10.1136/bmjopen-2024-095515.
- Individual participant dataSharing planned: Yes. Trial outcome data and essential baseline characteristics data are available upon request. Researchers interested in accessing the trial dataset should contact the corresponding author with details of their proposed research use. Data access will be provided subject to review and approval of the research protocol and execution of a data use agreement.
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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.
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?
A study testing adaptive cognitive training in people with Cognition and Diabetes Mellitus, Type 2, run by Fanfan Zheng 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 7 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: enrolling by invitation, as of the sponsor's last update on 4 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
Montreal Cognitive Assessment (MoCA) (time frame: baseline; "post-intervention, 12weeks"). 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 NCT06524388, which also lists 1 linked publication.
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 4 Dec 2025.