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HypertensionNCT06512922

Adaptive Cognitive Training on Cognitive Function in Elderly Hypertension Patients in the Community

A study testing adaptive cognitive training in people with Hypertension and Condition, run by Peking University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Objective A growing body of evidence supports hypertension as a risk factor for cognitive decline. Hypertension is significantly associated with accelerated cognitive decline, poorer cognitive function, and mild cognitive impairment and dementia. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Hypertension, Condition, 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

(1) Could not complete neuropsychological tests; (2) Suffering other disease or medication use might affect cognitive function, such as a new stroke within 6 months before baseline or use tranquilizers; (3) Unable to use PADs or unable to complete the training; (4) Unacceptable or refuse to participate in cognitive training; (5) Living in the same family with a subject who has been randomly assigned.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Xihuangcun Hospital

    Beijing, Shijingshan, 100144

Other trials in China

About this study

Official title: The Effects of COgNitive Training in Community-dwelling Older Adults at High Risk for demENTia and With Hypertension (CONTENT-Hypertension): a Randomized, Placebo-controlled Trial

Objective A growing body of evidence supports hypertension as a risk factor for cognitive decline. Hypertension 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 impairmentof 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 aged 60 years or older, diagnosis of hypertension, and cognitive function assessment showed no dementia.

Read more

Design The study was designed as a double-blind randomized controlled trial. 120 hypertension participants without dementia aged 60 years or older in Shijingshan 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 12 weeks and follow up to 24 weeks, 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 the end of the 12-week intervention.

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).

Being tested
adaptive cognitive training, placebo cognitive training
Medical subject headings
Hypertension, Disease

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

    They received cognitive training tasks of fixed difficulty.

Study groups in NCT06512922
Study groupRoleWhat they receive
adaptive cognitive trainingExperimentalThe intervention lasted for 12 weeks. Participants will receive 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 trainingActive comparatorThe intervention lasted for 12 weeks. Participants will receive 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.

  1. 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, attention 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, 12 weeks"

Secondary outcomes (9)

  1. Montreal Cognitive Assessment (MoCA)

    Description: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, attention 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

  2. 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. The investigators 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

  3. 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

  4. 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

  5. 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-intervetion; "post-intervention, 12 weeks"; 24 weeks follow-up

  6. Geriatric Depression Scale (GDS)

    Description: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"

  7. 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"

  8. 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"

  9. Blood pressure

    Systolic and diastolic blood pressure were measured using an Omron J-710 sphygmomanometer. Blood pressure will be measured three times with at least 30 seconds between each measurement.

    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.

  1. First posted22 Jul 2024
  2. Study start29 Oct 2024
  3. Primary completionSep 2026 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06512922
Sponsor's protocol ID
CMB22-466
Status last verified
Mar 2025
First submitted
11 Jul 2024
Last updated
12 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

Questions about this trial

What is this clinical trial studying?

A study testing adaptive cognitive training in people with Hypertension and Condition, run by Peking University 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?

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 12 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. 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, 12 weeks"). 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 NCT06512922, 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 12 Dec 2025.

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