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

Cognitive Function Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200234
• Other study ID #: ICC-PACS
• Status: Recruiting
• Phase: N/A
• Start date: January 13, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Min Lou, PhD, MD
• Phone: 13958007213
• Email: loumingxc[@]vip.sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carotid Stenosis
• Cerebral Blood Flow
• Cognitive Function
• Constriction, Pathologic

Intervention

Drug:
• Nattokinase
Nattokinase + standard treatment
• Placebo
Placebo+ standard treatment

Locations

Country	Name	City	State
China	Second Affilated Hospital of Zhejiang University, School of Medicine	HangZhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

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