Cerebral Blood Flow, Cognitive Function
Conditions
Keywords
Intracranial / Carotid Stenosis, Cerebral Blood Flow, Cognitive Function
Brief summary
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.
Interventions
DRUGNattokinase
Nattokinase + standard treatment
DRUGPlacebo
Placebo+ standard treatment
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the scores of Montreal Cognitive Assessment | 6 months | Total score of 30 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 Mini-mental State Examination | 6 months | Total score of 30 |
| 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 | 6 months | assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index) |
| Changes in metabonomics | 6 months | include blood and fecal samples |
| Changes in the scores of Animal Fluency Test | 6 months | — |
Countries
China
Contacts
Primary ContactMin Lou, PhD, MD
Outcome results
None listed