AzTrials
AzTrials

Vascular Cognitive Impairment No DementiaNCT06898931

Language Intervention Training for Cognitive Protection in High-risk Cardio-Cerebrovascular Elderly Population

A study testing Dialect Interpreting Training in people with Vascular Cognitive Impairment No Dementia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The global population is aging rapidly, with the number of elderly people with dementia projected to rise sharply, posing significant challenges to quality of life and societal burden.Frequent language switching, such as in interpreting, enhances cognitive abilities by improving attention, flexibility, and… Read more about this study

Who is it for?
Ages 60 years and older
What is being tested?
Dialect Interpreting Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
15 Apr 2025to 20 Sep 2026
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

  • Patients aged ≥ 60 years
  • High risk of stroke (with ≥ 3 of 8 stroke risk factors, including hypertension, dyslipidemia, diabetes, atrial fibrillation or valvular heart disease, smoking history, obvious overweight or obesity, lack of exercise, family history of stroke, or with transient ischemic attack)
  • command of Hangzhou dialect
  • Written informed consent available
  • Willingness to complete all assessments and participate in follow-up
  • Adequate Visual and auditory acuity to undergo neuropsychological testing

Who cannot join

  • previously diagnosed dementia
  • Suspected dementia after clinical assessment by study physician at screening visit
  • Previous history of major head trauma and any intracranial surgery
  • Intracranial abnormalities, such as intracerebral hemorrhage, subarachnoid hemorrhage and other space occupying lesions
  • Extrapyramidal symptoms or mental illness which may affect neuropsychological measurement
  • Severe loss of vision, hearing, or communicative ability
Show all 9Show fewer
  • Patients presenting a malignant disease with life expectancy < 3 years
  • Participation in an ongoing investigational drug study
  • Any MRI contraindications

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Min Lou, PhD, MD contact

057187783777

lm99@zju.edu.cn

About this study

Official title: A Study of Language Intervention Training for Cognitive Protection in High-risk Cardio-Cerebrovascular Elderly Population

The global population is aging rapidly, with the number of elderly people with dementia projected to rise sharply, posing significant challenges to quality of life and societal burden.Frequent language switching, such as in interpreting, enhances cognitive abilities by improving attention, flexibility, and memory.Dialect-switching training, similar to interpreting, is a non-invasive method that shows potential for promoting cognitive health in the elderly but remains under-researched.This study aims to investigate the cognitive-enhancing effects of a dialect-switching training program on older adults with vascular risk factors through a six-month intervention.

Read the detailed description

The global population is aging rapidly, with those aged 65+ expected to reach 16% of the total population by 2050. Aging is linked to increased cognitive impairment risks, including dementia prevalence rates of 5%-10% among the elderly in developed countries. In China, the number of elderly with dementia is projected to soar from 7.4 million to 18 million by 2030 without intervention. This trend poses significant challenges to quality of life and societal burden.

Language experiences, particularly frequent switching between languages, enhance cognitive abilities. Interpreting, which demands high-intensity language switching, significantly improves cognitive control and memory. Interpreters' need for rapid language conversion and reliance on attention, flexibility, and inhibition contribute to their cognitive advantages.

Similar to interpreting, switching between dialects and standard language requires high-frequency, high-intensity language conversion. This non-invasive training method is suitable for promoting cognitive health in the elderly. However, its potential benefits for cognitive enhancement in this population remain underexplored.

This study aims to design a dialect-switching training program simulating interpreting and investigate its potential cognitive-enhancing effects through a six-month intervention in older adults with vascular risk factors.

Being tested
Dialect Interpreting Training

What participants receive

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

  • Dialect Interpreting TrainingBehavioural

    The intervention group will receive a combination of offline and online language-switching training. The offline intervention will last for 2 months, with three training sessions per week, each lasting 1 hour. The training content will simulate the interpreting process, requiring participants to switch and convert rapidly and accurately between two dialects, covering multiple aspects including listening comprehension, oral expression, and information processing. The online intervention will last for 4 months, during which participants will regularly complete exercises through a language training app or website and upload their assignments.

Study groups in NCT06898931
Study groupRoleWhat they receive
RountineNo interventionThe control group will not receive any language intervention training and will maintain their usual daily routines.
Dialect Interpreting TrainingExperimentalThe intervention group will receive a combination of offline and online language-switching training. The offline intervention will last for 2 months, with three training sessions per week, each lasting 1 hour. The training content will simulate the interpreting process, requiring participants to switch and convert rapidly and accurately between two dialects, covering multiple aspects including listening comprehension, oral expression, and information processing. The online intervention will last for 4 months, during which participants will regularly complete exercises through a language training app or website and upload their assignments.
Receives: Behavioral: Dialect Interpreting Training

What is being measured

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

  1. Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)

    Primary Outcome

    Measured: 6 months

Secondary outcomes (46)
  1. Changes in brain functional network efficiency assessed by resting state fMRI

    long-term secondary outcome

    Measured: 2 years

  2. Changes in brain functional network activity intensity assessed by resting state fMRI

    long-term secondary outcome

    Measured: 2 years

  3. Changes in brain functional network efficiency assessed by resting state fMRI

    long-term secondary outcome

    Measured: 5 years

  4. Changes in brain functional network activity intensity assessed by resting state fMRI

    long-term secondary outcome

    Measured: 5 years

  5. Changes in brain functional network efficiency assessed by resting state fMRI

    short-term secondary outcome

    Measured: 6 months

  6. Changes in brain functional network activity intensity assessed by resting state fMRI

    short-term secondary outcome

    Measured: 6 months

  7. Changes in brain functional network connectivity assessed by resting state fMRI

    long-term secondary outcome

    Measured: 2 years

  8. Changes in brain functional network connectivity assessed by resting state fMRI

    long-term secondary outcome

    Measured: 5 years

  9. Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)

    short-term secondary outcome

    Measured: 6 months

  10. Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)

    long-term secondary outcome

    Measured: 2 years

  11. Global cognitive function change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)

    long-term secondary outcome

    Measured: 5 years

  12. Cognitive domain change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)

    short-term secondary outcome

    Measured: 6 months

  13. Cognitive domain change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)

    long-term secondary outcome

    Measured: 2 years

  14. Cognitive domain change assessed with Z-score of a modified National Institute of Neurological Disorders and Stroke and Canadian Stroke Network-Canadian Stroke Network (NINDS-CSN) protocol (higher scores mean a better outcome)

    long-term secondary outcome

    Measured: 5 years

  15. Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

    short-term secondary outcome

    Measured: 6 months

  16. Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

    long-term secondary outcome

    Measured: 2 years

  17. Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

    long-term secondary outcome

    Measured: 5 years

  18. Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

    short-term secondary outcome

    Measured: 6 months

  19. Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

    long-term secondary outcome

    Measured: 2 years

  20. Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)

    long-term secondary outcome

    Measured: 5 years

  21. Changes in white matter hyperintensity (WMH) assessed on MRI with T2-Fluid-Attenuated-Inversion-Recovery (FLAIR) sequence

    short-term secondary outcome

    Measured: 6 months

  22. Changes in lacunes assessed on MRI with T2 FLAIR sequence

    short-term secondary outcome

    Measured: 6 months

  23. Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence

    short-term secondary outcome

    Measured: 6 months

  24. Changes in microbleeds assessed on MRI with Susceptibility Weighted Imaging (SWI) sequence sequence

    short-term secondary outcome

    Measured: 6 months

  25. Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI

    short-term secondary outcome

    Measured: 6 months

  26. Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence

    long-term secondary outcome

    Measured: 2 years

  27. Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence

    long-term secondary outcome

    Measured: 5 years

  28. Changes in lacunes assessed on MRI with T2 FLAIR sequence

    long-term secondary outcome

    Measured: 2 years

  29. Changes in lacunes assessed on MRI with T2 FLAIR sequence

    long-term secondary outcome

    Measured: 5 years

  30. Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence

    long-term secondary outcome

    Measured: 2 years

  31. Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence

    long-term secondary outcome

    Measured: 5 years

  32. Changes in microbleeds assessed on MRI with SWI sequence sequence

    long-term secondary outcome

    Measured: 2 years

  33. Changes in microbleeds assessed on MRI with SWI sequence sequence

    long-term secondary outcome

    Measured: 5 years

  34. Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI

    long-term secondary outcome

    Measured: 2 years

  35. Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI

    long-term secondary outcome

    Measured: 5 years

  36. Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

    short-term secondary outcome

    Measured: 6 months

  37. Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

    long-term secondary outcome

    Measured: 2 years

  38. Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)

    long-term secondary outcome

    Measured: 5 years

  39. Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image

    short-term secondary outcome

    Measured: 6 months

  40. Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image

    long-term secondary outcome

    Measured: 2 years

  41. Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image

    long-term secondary outcome

    Measured: 5 years

  42. Metabolite profiles in participants' faecal samples and serum samples

    short-term secondary outcome: metabolite composition was analyzed via liquid chromatography tandem mass spectrometry (LC-MS/MS)

    Measured: 6 months

  43. Metabolite profiles in participants' faecal samples and serum samples

    long-term secondary outcome: metabolite composition was analyzed via liquid chromatography tandem mass spectrometry (LC-MS/MS)

    Measured: 2 years

  44. Incidence of stroke event including ischemic and hemorrhagic stroke

    short-term secondary outcome

    Measured: 6 months

  45. Incidence of stroke event including ischemic and hemorrhagic stroke

    long-term secondary outcome

    Measured: 2 years

  46. Incidence of stroke event including ischemic and hemorrhagic stroke

    long-term secondary outcome

    Measured: 5 years

Timeline

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

  1. First posted27 Mar 2025
  2. Study start15 Apr 2025 (estimated)
  3. Primary completion20 Apr 2026 (estimated)
  4. Study completion20 Sep 2026 (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
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06898931
Sponsor's protocol ID
Boost
Status last verified
Mar 2025
First submitted
20 Mar 2025
Last updated
27 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Dialect Interpreting Training in people with Vascular Cognitive Impairment No Dementia, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.

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 9 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: opening soon, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Min Lou, PhD, MD (057187783777, lm99@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI) (time frame: 6 months). 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 27 Mar 2025; AzTrials last refreshed its copy on 6 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in