Effect of Cerebrolysin on the Blood Brain Barrier in Patients With Diabetes and Ischemic Stroke

February 15, 2024 updated by: Juan Fernando Góngora Rivera, MD, PhD, Hospital Universitario Dr. Jose E. Gonzalez

The Effect of Cerebrolysin on the Blood-brain-barrier in Patients With Diabetes and Ischemic Stroke

A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier in patients with ischemic stroke with personal history of type-2 diabetes

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

A prospective, single-center study would be carried out in the Neurology Department of the University Hospital "Dr. José Eleuterio González" in order to analyze the effect of cerebrolysin on the blood-brain-barrier (BBB) in patients with ischemic stroke (IS) of the middle cerebral artery with personal history of type-2 diabetes (T2D).

The main objective is to compare the effect of cerebrolysin on the BBB in the above mentioned patients with intravenous thrombolysis (IVT) and without IVT.

The hypothesis of this study is that cerebrolysin can affect the BBB permeability after 10 days of the administration of this drug

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Monterrey
      • Nuevo León, Monterrey, Mexico, 64020
        • Recruiting
        • Servicio de Neurología del Hospital Universitario "Dr.José E. González"
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 - 80 years.
  2. Clinical and imaging criteria for ischemic stroke of the middle cerebral artery.
  3. Acute non-lacunar cerebral infarction.
  4. Cerebral infarction with a score on the NIH scale between 5 and 20 points.
  5. Patient with a previous diagnosis of type 2 diabetes mellitus, regardless of the form of diagnosis, time of evolution, previous or current treatment, adherence or not to treatment, presence or absence of microvascular and/or macrovascular complications.
  6. mRs ≤ 1 before the qualifying stroke (functionally independent for all activities of daily living).
  7. The patient and/or legal representative or direct family member has signed the informed consent form.

Exclusion Criteria:

  1. Advanced disease or terminal with life expectancy < 6 months.
  2. - Over 80 years old
  3. Lacunar infarction or small vessel disease.
  4. Pre-existing medical, neurological, or psychiatric disease that would confound neurological or functional evaluations (eg, Alzheimer's disease, vascular dementia, Parkinson's disease, demyelinating disease, encephalopathy of any cause, history of significant alcohol or drug abuse).
  5. Pregnancy or lactation.
  6. Acute or chronic renal failure with creatinine clearance <30 mL/min.
  7. Allergy or any condition that represents a contraindication for the administration of Cerebrolysin.
  8. Treatment with another investigational drug within the past 30 days that may interfere with the study drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intravenous thrombolysis and cerebrolysin

Group 1: 20 patients with previous intravenous thrombolysis (IVT) in the qualifying stroke and who agreed to receive and got selected (through randomization) cerebrolysin.

Cerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days
Drug: Cerebrolysin
Cerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days
Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin
Blood-brain barrier (BBB) disruption will be measured using dynamic susceptibility contrast (DSC) magnetic resonance imaging. DSC MRI is collected during the injection of a gadolinium bolus and the majority of the change in recorded signal in this T2-weighted sequence is due to intravascular contrast. However, in the setting of gadolinium leakage through the BBB into the brain parenchyma, the recorded signal is altered by a T1 effect. An arrival time correction is performed to account for regional difference in blood flow after which the signal is separated into an intravascular and an extravascular component using a comparison with unaffected tissue.The extravascular component is captured with the metric K2 which reflects the fraction of the recorded signal that is due to gadolinium leakage and is a measure of BBB disruption.
Active Comparator: Intravenous thrombolysis without cerebrolysin
Group 2 : 20 patients with previous IVT in the qualifying stroke and who agreed to receive cerebrolysin but they were not choose through randomization.
Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin
Blood-brain barrier (BBB) disruption will be measured using dynamic susceptibility contrast (DSC) magnetic resonance imaging. DSC MRI is collected during the injection of a gadolinium bolus and the majority of the change in recorded signal in this T2-weighted sequence is due to intravascular contrast. However, in the setting of gadolinium leakage through the BBB into the brain parenchyma, the recorded signal is altered by a T1 effect. An arrival time correction is performed to account for regional difference in blood flow after which the signal is separated into an intravascular and an extravascular component using a comparison with unaffected tissue.The extravascular component is captured with the metric K2 which reflects the fraction of the recorded signal that is due to gadolinium leakage and is a measure of BBB disruption.
Other: Patients with cerebrolysin without IVT

Group 3: 20 patients that they were not candidates to receive IVT (out of therapeutic window) but agreed to receive cerebrolysin (randomization not used)

Cerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days
Drug: Cerebrolysin
Cerebrolysin would be prepared according to manufacturer's instructions: 30 mL of cerebrolysin in 100 ml of saline solution every 24 hours to a minimum of 10 days and a maximum of 14 days
Procedure: Brain-MRI with contrast after 10-14 days of cerebrolysin
Blood-brain barrier (BBB) disruption will be measured using dynamic susceptibility contrast (DSC) magnetic resonance imaging. DSC MRI is collected during the injection of a gadolinium bolus and the majority of the change in recorded signal in this T2-weighted sequence is due to intravascular contrast. However, in the setting of gadolinium leakage through the BBB into the brain parenchyma, the recorded signal is altered by a T1 effect. An arrival time correction is performed to account for regional difference in blood flow after which the signal is separated into an intravascular and an extravascular component using a comparison with unaffected tissue.The extravascular component is captured with the metric K2 which reflects the fraction of the recorded signal that is due to gadolinium leakage and is a measure of BBB disruption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery
Time Frame: After 10-14 days of cerebrolysin
Blood-brain barrier (BBB) disruption will be measured using dynamic susceptibility contrast (DSC) magnetic resonance imaging (MRI).DSC MRI is collected during the injection of a gadolinium bolus and the majority of the change in recorded signal in this T2*-weighted sequence is due to intravascular contrast. However, in the setting of gadolinium leakage through the BBB into the brain parenchyma, the recorded signal is altered by a T1 effect. An arrival time correction is performed to account for regional difference in blood flow after which the signal is separated into an intravascular and an extravascular component using a comparison with unaffected tissue. The extravascular component is captured with the metric K2 which reflects the fraction of the recorded signal that is due to gadolinium leakage and is a measure of BBB disruption.
After 10-14 days of cerebrolysin

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin
Time Frame: After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
The NIH Stroke Scale would be measured in all patients in the indicated time frames, and the results would be compared based among the 3 groups
After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin
Time Frame: After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
The modified Rankin scale would be measured in all patients in the indicated time frames, and the results would be compared based among the 3 groups
After 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin
Time Frame: fter 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge
The Montreal Cognitive Assessment would be measured in all patients in the indicated time frames, and the results would be compared based among the 3 groups
fter 10-14 days of cerebrolysin, and 30 days and 90days after hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez

Collaborators

Ever Neuro Pharma GmbH

Investigators

  • Principal Investigator: Juan F Góngora-Rivera, Ph.D., Hospital Universitario Dr. Jose E. Gonzalez

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2022

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 15, 2024

First Submitted That Met QC Criteria

February 15, 2024

First Posted (Estimated)

February 22, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MI22-00013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The individual participant data would be shared upon reasonable request after the publication of this trial in an indexed journal

IPD Sharing Time Frame

Anytime after the publication of this trial in an indexed journal

IPD Sharing Access Criteria

Design of meta-analysis When in doubt of the veracity of the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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