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

Not Applicable

Recruiting

• Conditions: Cerebral Blood Flow; Cognitive Function
• Interventions: Drug: Nattokinase; Drug: Placebo

• Registration Number: NCT05200234
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-13
• Study First Submitted: 2022-01-17
• Study First Submitted QC: 2022-01-17
• Study First Posted: 2022-01-20
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-18
• Primary Completion: 2023-07-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Nattokinase	Nattokinase + standard medical treatment
Control group	Placebo	Placebo + Standard medical treatment

Primary Outcome Measures

Name	Time	Method
Changes in the scores of Montreal Cognitive Assessment	6 months	Total score of 30

Secondary Outcome Measures

Name	Time	Method
Changes in the scores of Animal Fluency Test	6 months
Changes in the scores of Olfactory stick test	6 months
Changes in the scores of clock drawing test	6 months
Changes in metabonomics	6 months	include blood and fecal samples
Changes in cerebral blood flow in the territory of the culprit artery	6 months
Changes in the scores of Mini-mental State Examination	6 months	Total score of 30
Changes in the scores of Hopkins Verbal Learning Test	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 the scores of Colour Trail Test	6 months
Incidence of stroke event including ischemic and hemorrhagic stroke	6 months

Trial Locations

Locations (1)

Second Affilated Hospital of Zhejiang University, School of Medicine; 🇨🇳 HangZhou, Zhejiang, China