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Table 1 Inclusion and exclusion criteria of End-PSCI

From: Protocol of End-PSCI trial: a multicenter, randomized controlled trial to evaluate the effects of DL-3-n-butylphthalide on delayed-onset post stroke cognitive impairment

Inclusion criteria

1. Age ranges from 50 to 75 years (50 and 75 also included), no gender limitation.

2. Meet the diagnostic criteria of Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018a [23].

3. Brain MRI provides evidences for the diagnosis of acute cerebral infarction.

4. No disturbance of consciousness, evident aphasia or severe paralysis.

5. Educational level should be primary school or above, with capability of finishing cognitive tests.

6. Signed written informed consent.

Exclusion criteria

1. Patients treated by intravenous or arterial thrombolysis or endovascular interventional therapy.

2. Patients with secondary hemorrhage or hematoma after cerebral infarction.

3. Patients with pre-stroke cognitive impairment.

4. Patients with other severe central nervous systematic diseases: Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, frontotemporal dementia, neuromyelitis optica, epilepsy, central nervous system infection, cerebral injury, cerebral tumor, etc.

5. Patients with mental disorders diagnosed by the Diagnostic and Statistical Manual of Mental Disorders—Fourth Edition Text Revision (DSM-IV-TR) [24], including schizophrenia, bipolar affective disorder, major depressive disorder or delirium, etc.

6. Patients are taking cholinesterase inhibitors, Memantine or NBP.

7. Patients with uncorrectable visual or hearing disturbances severe enough to preclude cognitive tests.

8. Patients with unstable or severe cardiovascular, respiratory, gastrointestinal, hepatic, renal or hematopoietic system disease.

9. Unable to perform MRI tests.

10. Patients who are unwilling or unable to comply with the protocol or cannot/will not cooperate fully with the investigator.

  1. aThe following should all be met: 1) Acute onset; 2) With focal neurological function defects (e.g. one side limb weakness, numbness of one side of the face or language disorders), a few with general neurological function defects; 3) Responsible lesions on imaging or symptoms/signs lasted more than 24 h; 4) Excluded non-vascular etiology; 5) Brain CT/MRI excluded cerebral hemorrhage