Clinical trial NCT06898931: Language Intervention Training for Cognitive Protection in High-risk Cardio-Cerebrovascular Elderly Population
Official title: A Study of Language Intervention Training for Cognitive Protection in High-risk Cardio-Cerebrovascular Elderly Population
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vascular Cognitive Impairment No Dementia
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Patients presenting a malignant disease with life expectancy \< 3 years
* Participation in an ongoing investigational drug study
* Any MRI contraindications

Primary outcomes:
measure: Changes in brain functional network connectivity assessed by resting state functional magnetic resonance imaging (fMRI)
timeFrame: 6 months
Secondary outcomes:
measure: Changes in brain functional network efficiency assessed by resting state fMRI
timeFrame: 2 years
measure: Changes in brain functional network activity intensity assessed by resting state fMRI
timeFrame: 2 years
measure: Changes in brain functional network efficiency assessed by resting state fMRI
timeFrame: 5 years
measure: Changes in brain functional network activity intensity assessed by resting state fMRI
timeFrame: 5 years
measure: Changes in brain functional network efficiency assessed by resting state fMRI
timeFrame: 6 months
measure: Changes in brain functional network activity intensity assessed by resting state fMRI
timeFrame: 6 months
measure: Changes in brain functional network connectivity assessed by resting state fMRI
timeFrame: 2 years
measure: Changes in brain functional network connectivity assessed by resting state fMRI
timeFrame: 5 years
measure: 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)
timeFrame: 6 months
measure: 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)
timeFrame: 2 years
measure: 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)
timeFrame: 5 years
measure: 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)
timeFrame: 6 months
measure: 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)
timeFrame: 2 years
measure: 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)
timeFrame: 5 years
measure: Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
timeFrame: 6 months
measure: Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
timeFrame: 2 years
measure: Cognitive function change assessed with Mini-Mental State Examination (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
timeFrame: 5 years
measure: Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
timeFrame: 6 months
measure: Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
timeFrame: 2 years
measure: Cognitive function change assessed by Montreal Cognitive Assessment (minimum value = 0, maximum value = 30, and higher scores mean a better outcome)
timeFrame: 5 years
measure: Changes in white matter hyperintensity (WMH) assessed on MRI with T2-Fluid-Attenuated-Inversion-Recovery (FLAIR) sequence
timeFrame: 6 months
measure: Changes in lacunes assessed on MRI with T2 FLAIR sequence
timeFrame: 6 months
measure: Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence
timeFrame: 6 months
measure: Changes in microbleeds assessed on MRI with Susceptibility Weighted Imaging (SWI) sequence sequence
timeFrame: 6 months
measure: Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI
timeFrame: 6 months
measure: Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence
timeFrame: 2 years
measure: Changes in white matter hyperintensity (WMH) assessed on MRI with T2 FLAIR sequence
timeFrame: 5 years
measure: Changes in lacunes assessed on MRI with T2 FLAIR sequence
timeFrame: 2 years
measure: Changes in lacunes assessed on MRI with T2 FLAIR sequence
timeFrame: 5 years
measure: Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence
timeFrame: 2 years
measure: Changes in perivascular spaces assessed on MRI with T2 FLAIR sequence
timeFrame: 5 years
measure: Changes in microbleeds assessed on MRI with SWI sequence sequence
timeFrame: 2 years
measure: Changes in microbleeds assessed on MRI with SWI sequence sequence
timeFrame: 5 years
measure: Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI
timeFrame: 2 years
measure: Changes in brain atrophy (width of the sulci greater than 5mm) assessed on MRI
timeFrame: 5 years
measure: Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
timeFrame: 6 months
measure: Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
timeFrame: 2 years
measure: Changes in cerebral glymphatic function assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
timeFrame: 5 years
measure: Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image
timeFrame: 6 months
measure: Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image
timeFrame: 2 years
measure: Changes in cerebral blood flow (CBF) in the territory of the culprit artery assessed by arterial spin labeling (ASL) perfusion image
timeFrame: 5 years
measure: Metabolite profiles in participants' faecal samples and serum samples
timeFrame: 6 months
measure: Metabolite profiles in participants' faecal samples and serum samples
timeFrame: 2 years
measure: Incidence of stroke event including ischemic and hemorrhagic stroke
timeFrame: 6 months
measure: Incidence of stroke event including ischemic and hemorrhagic stroke
timeFrame: 2 years
measure: Incidence of stroke event including ischemic and hemorrhagic stroke
timeFrame: 5 years
Other outcomes:
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