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

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

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

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.