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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06273020
• Other study ID #: MI22-00013
• Status: Recruiting
• Phase: Phase 4
• Start date: November 17, 2022
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: Juan F Góngora-Rivera, Ph.D.
• Phone: +528115163257
• Email: fernando.gongora[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Blood Brain Barrier
• Cerebral Infarction
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Mexico	Servicio de Neurología del Hospital Universitario "Dr.José E. González"	Nuevo León	Monterrey

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez	Ever Neuro Pharma GmbH

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood-Brain-Barrier Permeability after 10-14days of cerebrolysin in patients with AIS of the middle cerebral artery	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	Comparison of clinical severity, using NIH Stroke Scale in patients with and withouth cerebrolysin	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
Secondary	Comparison of functional prognosis, using modified Rankin scale in patients with and withouth cerebrolysin	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
Secondary	Comparison of cognitive impairment, using Montreal Cognitive Assessment in patients with and withouth cerebrolysin	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