AzTrials
AzTrials

Mild Cognitive ImpairmentNCT05704270

Computerized Cognitive Training to Protect Cognitive Function Among Hypertension Patients

A study testing Multi-domain adaptive cognitive training and Basic cognitive training with no difficulty change in people with Mild Cognitive Impairment and Hypertension, run by Beijing Anzhen Hospital at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Hypertension is an risk factor for cognitive impairment. The primary objective of this study is to evaluate the efficacy of 12-week computerized cognitive training in people with hypertension and mild cognitive impairment. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Mild Cognitive Impairment, Hypertension
What is being tested?
Multi-domain adaptive cognitive training and Basic cognitive training with no difficulty change
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
2 sitesChina
Study dates
1 Feb 2023to 30 Mar 2025
Phase
Interventional
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Older than 60 years;
  • Completed 6 or more years of education;
  • Untreated or under treatment hypertension;
  • Complaint of memory decline within 1 year;
  • Global cognitive score measured by the Montreal Cognitive Assessment is below 26;
  • Agree to receive cognitive function evaluation, randomization, and follow-up investigation as required;

Who cannot join

  • Unable to complete cognitive function evaluation due to vision, hearing, and other problems;
  • Have been diagnosed of dementia or MMSE score ≤ 20;
  • Unable to use the cognitive training equipment after 2 times instructions;
  • Alcohol abuse or taking drugs that could affect cognitive function (antihistamines, antipsychotics);
  • Diabetes patients;
  • Moderate to severe decrease in glomerular filtration rate (eGFR<30 ml/min /1.73m2);
Show all 17Show fewer
  • Systolic blood pressure ≥180 mmHg or/and diastolic blood pressure ≥110 mmHg; or orthostatic hypotension (defined as the third standing SBP<100mmHg);
  • History of cardiovascular events or hospitalization due to cardiovascular diseases in the last 3 months;
  • Planned to receive coronary intervention, atrial fibrillation ablation or cardiac surgery within 6 months; or have received these intervention strategies in the last 3 months;
  • Symptomatic heart failure or left ventricular ejection fraction <50%；
  • Atrial fibrillation confirmed by ECG with marked and severe onset of symptoms;
  • A history of stroke, or head injury in the last 6 months; past history of brain tumor or neurosurgery;
  • Past history of Parkinson's disease, Alzheimer's disease, schizophrenia, and epilepsy;
  • Have Ever undergone surgery under general anesthesia in the last three months;
  • Severe hepatic impairment or in critical condition patients with very poor prognosis whose expected survival is less than 6 months; or diagnosed of malignant tumor other than non-melanoma skin cancer in the last 2 years;
  • Contradictions for MRI examination: such as metal implantation, claustrophobia, etc.;
  • Unable to obtain an informed consent or currently taking part in other clinical trials

Trial locations and contacts

2 sites in 1 country.

Yu Kong contact

086-13811901076

ky5166@126.com

China2 sites

  • Beijing Anzhen Hospital

    Beijing

    Yu Kong

  • Ruijing Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

    Qianhui Guo

Other trials in China

About this study

Official title: The Efficacy of Computerized Cognitive Training in Patients With Hypertension and Cognitive Impairment, no Dementia: a Randomized Controlled Trial

Hypertension is an risk factor for cognitive impairment. The primary objective of this study is to evaluate the efficacy of 12-week computerized cognitive training in people with hypertension and mild cognitive impairment. The researchers will further investigate the long-term effects of cognitive training by prolonging the intervention for 24 weeks among a randomly selected sub-group.

Read the detailed description

This study is a double-blinded, randomized controlled trial. A total of 200 hypertension patients with mild cognitive impairment will be recruited to participate in this study after screening. These patients will be randomized to two arms under masking. The intervention arm will receive multi-domain adaptive cognitive training using a tablet. The control arm will receive an active control treatment and use the same tablet to receive the cognitive training tasks with weak difficulty change. Both arms will receive the same intervention dosage for 12 weeks, 5 times a week, and 30 minutes per time. After the 12-week intervention, the intervention arm will be re-randomized into two groups. One group will stop their intervention at 12 weeks; the other group will continue to receive the multi-domain adaptive cognitive training till the 24-week follow-up assessment.

The neuro-psychological assessment will be administered at baseline, 12-week, and 24-week assessments for all participants. The structural and functional MRI will be administered at baseline, 12 weeks, and 24 weeks to evaluate the effect of cognitive training on brain structure and function.

Being tested
Multi-domain adaptive cognitive training, Basic cognitive training with no difficulty change
Keywords
Cognitive training, Digital health, Hypertension
Medical subject headings
Cognitive Dysfunction, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-domain adaptive cognitive trainingBehavioural

    The multi-domain adaptive cognitive training covers seven aspects of fundamental cognitive function, including sensory perception, cognitive flexibility, attention, memory, language, logic calculation, and emotion recognition and management. A self-adaptive algorithm is embedded in the tablet-based cognitive training platform, which will help deliver suitable tasks at the right difficulty level for each participant according to their personal profile and real-time performance. The intervention dosage is 30 minutes per time, 5 times a week.

  • Basic cognitive training with no difficulty changeBehavioural

    The basic cognitive training for the control arm will also be delivered via a tablet. The training tasks will be fixed at a primary difficulty level without adaptive algorithm. The intervention dosage is also 30 minutes per time, 5 times a week.

Study groups in NCT05704270
Study groupRoleWhat they receive
Adaptive cognitive trainingExperimentalThis arm is the intervention arm. Participants randomized to this arm will use a tablet to receive the multi-domain adaptive cognitive training, which will be delivered 30 minutes at least 5 times a week for 12 weeks.
Receives: Behavioral: Multi-domain adaptive cognitive training
Active controlActive comparatorThis arm is the control arm. Participants randomized to this arm will use the same tablet to receive the cognitive training of low difficulty level with no adaptive change. The intervention dosage will be the same, which is 30 minutes each time, at least 5 times a week for 12 weeks.
Receives: Behavioral: Basic cognitive training with no difficulty change

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global cognitive function change measured by BCAT in 12 weeks

    The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function measured by Basic Cognitive Ability Test (BCAT). BCAT is a set of neuropsychological battery tests which was designed to measure global cognitive fucntion and cognitive function of sub-domains. Higher scores of BCAT means a better global cognitive function.

    Measured: 12 weeks after randomization

Secondary outcomes (7)

  1. Global cognitive function change measured by BCAT in 24 weeks

    The proportion of patients whose global cognitive function improves 0.67SD compared to the baseline cognitive function at 24 weeks measured by Basic Cognitive Ability Test(BCAT).

    Measured: 24 weeks after randomization

  2. Sub-domain cognitive function improvement including memory, attention, and execution memory

    The proportion of patients whose sub-domain cognitive function, including attention, memory, execution function improves measured by the individual capability test in BCAT.

    Measured: 12 weeks, 24 weeks after randomization

  3. Cognitive score change

    Mean change from baseline in global cognitive function score measured by basic cognitive ability test (BCAT) at 12 weeks and 24 weeks.

    Measured: 12 weeks, 24 weeks after randomization

  4. Self-efficacy score

    Mean change from baseline in self-efficacy score measured by the General Self-Efficacy Scale at 12 weeks, and 24 weeks

    Measured: 12 weeks, 24 weeks after randomization

  5. Quality of life score

    Mean change from baseline in the patient's quality of life score measured by EQ-5D-3L at 12 weeks and 24 weeks.

    Measured: 12 weeks, 24 weeks after randomization

  6. Anxiety score

    Mean change from baseline in the patient's anxiety score at 12 weeks and 24 weeks. Anxiety status will be measured by GAD-7 questionnaire. Higher score of GAD-7 scale represents more anxiety status.

    Measured: 12 weeks, 24 weeks after randomization

  7. Depression score

    Mean change from baseline in the patient's depression score at 12 weeks and 24 weeks. Depression status will be measured by PHQ-9 questionnaire. Higher score of PHQ-9 scale represents more depression status.

    Measured: 12 weeks, 24 weeks after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2023
  2. Study start1 Feb 2023 (estimated)
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion30 Mar 2025 (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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05704270
Sponsor's protocol ID
2022BFAZ01
Status last verified
Jan 2023
First submitted
9 Jan 2023
Last updated
30 Jan 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kong Y, Guo QH, Zhou L, He L, Zeng Y, Du X, Dong JZ, Jiang C, Wang JG, Ma CS. Digital computerised cognitive training for preventing cognitive decline among hypertensive patients: a study protocol for a multicentre randomised controlled trial (DELIGHT trial). BMJ Open. 2024 Feb 29;14(2):e079305. doi: 10.1136/bmjopen-2023-079305.

    PubMed 38423771

Questions about this trial

What is this clinical trial studying?

A study testing Multi-domain adaptive cognitive training and Basic cognitive training with no difficulty change in people with Mild Cognitive Impairment and Hypertension, run by Beijing Anzhen Hospital at 2 sites 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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yu Kong (086-13811901076, ky5166@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global cognitive function change measured by BCAT in 12 weeks (time frame: 12 weeks after randomization). 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 NCT05704270, 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 30 Jan 2023; AzTrials last refreshed its copy on 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in