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

Primary Purpose

Cerebral Blood Flow, Cognitive Function

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nattokinase
Placebo
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Blood Flow focused on measuring Intracranial / Carotid Stenosis, Cerebral Blood Flow, Cognitive Function

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Second Affilated Hospital of Zhejiang University, School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Control group

Arm Description

Nattokinase + standard medical treatment

Placebo + Standard medical treatment

Outcomes

Primary Outcome Measures

Changes in the scores of Montreal Cognitive Assessment
Total score of 30

Secondary Outcome Measures

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

Full Information

First Posted
January 17, 2022
Last Updated
April 16, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05200234
Brief Title
Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS)
Acronym
ICC-PACS
Official Title
Improving Cerebral Blood Flow and Cognitive Function in Patients With Asymptomatic Intracranial / Carotid Stenosis With Nattokinase (ICC-PACS): a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Blood Flow, Cognitive Function
Keywords
Intracranial / Carotid Stenosis, Cerebral Blood Flow, Cognitive Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Nattokinase + standard medical treatment
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo + Standard medical treatment
Intervention Type
Drug
Intervention Name(s)
Nattokinase
Intervention Description
Nattokinase + standard treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo+ standard treatment
Primary Outcome Measure Information:
Title
Changes in the scores of Montreal Cognitive Assessment
Description
Total score of 30
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Changes in the scores of Mini-mental State Examination
Description
Total score of 30
Time Frame
6 months
Title
Changes in cerebral blood flow in the territory of the culprit artery
Time Frame
6 months
Title
Changes in the scores of Colour Trail Test
Time Frame
6 months
Title
Changes in the scores of Hopkins Verbal Learning Test
Time Frame
6 months
Title
Changes in the scores of clock drawing test
Time Frame
6 months
Title
Changes in the scores of Animal Fluency Test
Time Frame
6 months
Title
Changes in the scores of Olfactory stick test
Time Frame
6 months
Title
Incidence of stroke event including ischemic and hemorrhagic stroke
Time Frame
6 months
Title
Changes in cerebral glymphatic function
Description
assessed by non-invasive diffusion tensor image analysis along the perivascular space (ALPS-index)
Time Frame
6 months
Title
Changes in metabonomics
Description
include blood and fecal samples
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Lou, PhD, MD
Phone
13958007213
Email
loumingxc@vip.sina.com
Facility Information:
Facility Name
Second Affilated Hospital of Zhejiang University, School of Medicine
City
HangZhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Lou, PhD, MD
Phone
13958007213
Email
lm99@zju.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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