Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS)

Study Overview
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Brief Summary
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A randomized controlled trial will be conducted. Patients with asymptomatic intracranial / carotid stenosis will be randomized into two arms (1:1): an intervention arm and a control arm. Patients in the intervention arm will be treated with standard medical treatment combined with Natto Products V, whereas Patient in the control arm will be treated with only standard medical treatment . And the impact of Natto Products V on improving cerebral blood flow and cognitive function in patients with asymptomatic intracranial / carotid stenosis will be assessed by neuropsychological scale and multimode magnetic resonance imaging.

Official Title
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Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS): a Randomized Controlled Trial

Conditions
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Cerebral Blood Flow, Cognitive Function

Intervention / Treatment
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* Drug: Nattokinase
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged ≥ 40 years ≥ 50% stenosis in unilateral intracranial / carotid artery Written informed consent available Exclusion Criteria: 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 plan to be treated with surgery

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Nattokinase + standard medical treatment | Drug: Nattokinase<br>* Nattokinase + standard treatment<br>|
| Placebo Comparator: Control group<br>Placebo + Standard medical treatment | Drug: Placebo<br>* Placebo+ standard treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the scores of Montreal Cognitive Assessment | Total score of 30 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the scores of Mini-mental State Examination | Total score of 30 | 6 months | 
| Changes in cerebral blood flow in the territory of the culprit artery |  | 6 months | 
| Changes in the scores of Colour Trail Test |  | 6 months | 
| Changes in the scores of Hopkins Verbal Learning Test |  | 6 months | 
| Changes in the scores of clock drawing test |  | 6 months | 
| Changes in the scores of Animal Fluency Test |  | 6 months | 
| Changes in the scores of Olfactory stick test |  | 6 months | 
| Incidence of stroke event including ischemic and hemorrhagic stroke |  | 6 months | 
| Changes in cerebral glymphatic function | assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index) | 6 months | 
| Changes in metabonomics | include blood and fecal samples | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracranial / Carotid Stenosis, Cerebral Blood Flow, Cognitive Function