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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Blood Flow; Cognitive Function
• Intervention / Treatment: Drug: Nattokinase; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • HangZhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affilated Hospital of Zhejiang University, School of Medicine
      • Contact: Min Lou, PhD, MD; Phone Number: 13958007213; Email: lm99@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Nattokinase + standard medical treatment	Drug: Nattokinase; Nattokinase + standard treatment
Placebo Comparator: Control group; Placebo + Standard medical treatment	Drug: Placebo; Placebo+ standard treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2022
• Primary Completion (Anticipated): July 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: January 17, 2022
• First Submitted That Met QC Criteria: January 17, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 16, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Cognitive Function; Cerebral Blood Flow; Intracranial / Carotid Stenosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Carotid Artery Diseases; Carotid Stenosis; Constriction, Pathologic
• Other Study ID Numbers: ICC-PACS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No