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

Launched by HOSPITAL UNIVERSITARIO DR. JOSE E. GONZALEZ · Feb 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called cerebrolysin on the blood-brain barrier in patients who have experienced an ischemic stroke, particularly those with a history of type 2 diabetes. The blood-brain barrier is a protective shield that helps keep harmful substances out of the brain. The goal of the study is to see if cerebrolysin can help improve the function of this barrier in stroke patients, which may lead to better recovery outcomes.

To participate in the trial, individuals need to be between 18 and 80 years old and have had a specific type of stroke that affects the middle part of the brain. They should also have a history of type 2 diabetes and have been functionally independent before the stroke occurred. Participants will go through a careful selection process and, if eligible, will receive detailed information and support during the study. It's important to know that people with certain health conditions or those who are pregnant cannot participate. Overall, this trial aims to find new ways to support recovery in patients who are facing the challenges of stroke and diabetes.

Gender

ALL

Eligibility criteria

• 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.