Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke
Brief Summary: The study investigated the clinical efficacy and safety of a 10-day course of therapy with daily intravenous administration of 30mL Cerebrolysin based on a comparison with Placebo in patients with acute ischemic stroke. 1070 patients were randomized in this trial in 2 parallel groups, one receiving Cerebrolysin, the control group receiving Placebo. Study drug will be given once daily by intravenous infusion for 10 consecutive days. Acetylsalicylic acid will be given orally, once daily throughout the study duration of 90 days as basic treatment. The clinical observation period for each patient will be 3 months and will include six clinical evaluation visits at Baseline (day 1) and on study days 2, 5, 10, 30 and 90.


Options:
A: Inclusion criteria

* Diagnosis of probable AD (Diagnostic and Statistical Manual of Mental Disorders, 4th revision \[DSM-IV\], National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association \[NINCDS-ADRDA\])
* Mini-Mental-State-Examination (MMSE) of 12-25, inclusive
* Modified Hachinski score ≤4
* Computed tomography (CT) or magnetic resonance imaging (MRI) scan within 12 months prior to screening without evidence of infection, infarction, or other focal lesions and without clinical symptoms suggestive of intervening neurological disease. Patients who have had a single, clinically silent lacunar infarct are eligible provided the lacunar infarct is not felt to be responsible for the patient's symptoms, is \<1 centimeter (cm) maximal diameter in any dimension, is not present in hippocampus of either hemisphere, head of the left caudate, or the dorsomedial region of the left thalamus. Subjects with scans showing atrophy, ventricular enlargement or mild to moderate white matter changes (involving up to approximately 25% of hemispheric white matter) are eligible if the study is otherwise normal.
* Hamilton Depression Scale score of ≤15
* Adequate visual and auditory acuity to allow neuropsychological testing
* Ability to attempt all sections of the Alzheimer's Disease Assessment Scale Cognitive Subpart (extended version)(ADAS-cog+)
* Good general health without additional diseases expected to interfere with the study
* Normal B12, folic acid, venereal disease research laboratory (VDRL), and thyroid-stimulating hormone (TSH) or without any clinically significant laboratory abnormalities that would be expected to interfere with the study
* Electrocardiogram (ECG) and chest x-ray (if clinically necessary per Investigator) without clinically significant laboratory abnormalities that would be expected to interfere with the study
* Patient is not institutionalized
* Patient is not pregnant, lactating, or of childbearing potential
* Sufficient language skills to complete all testing without assistance of a language interpreter
* Responsible caregiver being present during administration of study drug, monitor the patient's compliance with study procedures and adverse events, and accompany the patient to all clinic visits
* Written informed consent obtained from the patient and caregiver prior to entry into the study

Exclusion criteria

* Any clinically significant laboratory abnormalities on the battery of screening tests
* Patients who in the past have not tolerated treatment with 10 mg Aricept or treatment with a corresponding dose of another cholinesterase inhibitor
* Severe psychotic features, depression, agitation or behavioral problems within the last three months that could lead to difficulty complying with the protocol
* Any significant systemic illness or unstable medical condition that could lead to difficulty complying with the protocol
* Patients who in the Investigator's opinion would not comply with study procedures
* Any significant neurological disease other than Alzheimer's Disease, within the past five years, or with residual effects
* Delusional symptoms are often characteristic of Alzheimer's Disease, but patients with symptoms so pronounced that they warrant an alternative diagnosis are excluded
* History of alcohol or substance abuse or dependence within the past two years (DSM-IV)
* History of schizophrenia (DSM-IV)
* Patients with a history of systemic cancer within the past two years are excluded
* History of myocardial infarction in the past year or unstable or severe cardiovascular disease, including uncontrolled hypertension
* Uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus (Haemoglobin A1c \[HBA1c\] \> 10.0)
* Use of:

  * systemic corticosteroids for more than one week within three months prior to Baseline (BL)
  * Anti-Parkinsonian agents within two months prior to baseline (BL)
  * Approved or investigational Cholinesterase Inhibitors within 30 days or five half-lives, whichever is longer, prior to BL
  * Memantine or other N-methyl-D-aspartic acid (NMDA) antagonists within 30 days or five half-lives, whichever is longer, prior to BL
  * Treatment with high potency neuroleptics or narcotic analgesics within four weeks prior to BL
  * Cimetidine within four weeks prior to BL
  * Sedatives more frequently than two times per week for sleep within four weeks prior to BL
B: Inclusion Criteria:

* Acute ischemic stroke within 12 hours for the first time before entry into the study
* National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25

Exclusion Criteria:

* with lacunar infarction
* with cerebral hemorrhagic infarction
* with epilepsy or epileptic persons
* with history of neurological diseases
* with myocardial infarction,
* with renal and hepatic abnormalities
* with metabolic diseases
* with contraindications to antiplatelet treatments
C: Inclusion Criteria:

* Age between 18 and 85 years
* Focal neurological deficit
* Clinical diagnosis of acute hemispheric ischemic stroke
* CT or MRI results compatible with clinical diagnosis of acute hemispheric stroke
* NIH Stroke Scale Score between 6 and 22, both inclusive
* Functionally independent prior to stroke with a pre-stroke Rankin Score of 0 or 1
* Randomization and first treatment with the trial medication within 12h after stroke onset
* Informed consent given by the patient and/or the patient's legally acceptable representative

Exclusion Criteria:

* Evidence on CT/MRI of acute or chronic intracerebral hemorrhage, SAH, AVM, cerebral aneurysm, or neoplasm
* Signs of herniation, increased intracranial pressure or likely etiology other than brain ischemia at baseline CT scan
* Patients with a substantial decrease of consciousness or alertness at the time of randomization, defined as score of 2 or more one of the NIH Stroke Scale questions 1a.
* Neurological signs and symptoms that improve rapidly during screening and are likely to resolve completely within 24h
* Severe coexisting systemic disease that significantly limits life expectancy
* Systolic blood pressure over 220 mmHg or diastolic blood pressure over 120 mmHg on repeated measurement (interval of 30 min) prior to study entry
* Severe congestive heart failure or presentation with acute myocardial infarction at study entry
* Epilepsy or epileptic seizures at onset of stroke
* Pre-existing disorders or conditions that would impair interpretation of neurological assessment (eg. severe dementia, severe psychiatric illnesses, etc).
* Concomitant treatment with other neuroprotective or nootropic drugs (e.g. piracetam, citicoline, investigational neuroprotective substances)
* Patients which cannot tolerate or have contraindication to aspirin or Cerebrolysin treatment
* Concomitant treatment with substances that have a dilative effect on blood vessels like naftidrofuryl, cinnarizine, flunarizine or nimodipine
* Pregnancy and lactation period; for women with child-bearing potential a negative pregnancy test is required
* Participation in a clinical trial with an investigational drug in the past 4 weeks
D: Inclusion Criteria:

1. 1st cortical or subcortical unilateral infarction (supratentorial lesion)
2. Confirmed by CT or MRI
3. Subacute stage: less than 1 week
4. Moderate to severe motor function involvement-total of FMA: 0-84
5. Age: between 18 and 80 years
6. Inpatients

Exclusion Criteria:

1. Progressive or unstable stroke
2. Pre-existing and active major neurological disease
3. Pre-existing and active (e.g., on chronic medication) major psychiatric disease, such as major depression, schizophrenia, bipolar disease, or dementia
4. A history of significant alcohol or drug abuse in the prior 3 years
5. Advanced liver, kidney, cardiac, or pulmonary disease
6. A terminal medical diagnosis consistent with survival \< 1 year
7. Substantial decrease in alertness at the time of randomization, defined as score of 2 on NIH Stroke Scale
8. Pregnancy or lactating; note that a negative pregnancy test will be required if the patient is a female in reproductive years
9. Any condition that would represent a contraindication to Cerebrolysin, including allergy to Cerebrolysin
10. Current enrolment in another therapeutic study of stroke or stroke recovery
11. Total serum bilirubin \> 4 mg/dL, alkaline phosphatase \> 250 U/L, SGOT/AST \> 150 U/L, SGPT/ALT \> 150 U/L, or creatinine \> 3.5 mg/dL; or cardiopulmonary deficits large enough to interfere with reasonable participation in physiotherapy during the trial.
12. Previous porcine brain peptide administration history

Answer: C