Efficacy and Safety of Qi Zhi Tong Luo Capsule in Vascular Cognitive Impairment

Inclusion Criteria:

1. Decline in cognitive function from a prior baseline and impairment in at least 1cognitive domain, the domain of cognition including executive function(Trail MakingTest-part A(Chinese version,150s)>98s)), memory function decline (Hopkins verballearning test free recall(36 points) <18.5 points), language function decline (Bostonnaming test (Chinese version 30 items)<22 points), and visuo-spatial functions (Clockdrawing test(10 points)<8.5 points) ;

2. Evidence of cerebrovascular disease relies on structural magnetic resonance imaging (MRI) , history and clinical feature. The neuroimaging should include at least one offollowing: a) a single large vessel infarction which was sufficient to cause cognitiondecline; b) infarction at a single strategic place was sufficient to cause severecognition decline( the thalamus, angular gyrus, and basal ganglia, including thecaudate nucleus and globus pallidus); c) multiple lacunar infarctions (≥3) outside thebrainstem, or 2 lacunar infarcts at key locations, a single lacunar focus withextensive white matter lesions(WMLs) ; d) extensive and integrated WMLs(Fazekasscale≥3 points) ; e) intracranial hemorrhage in key parts, or ≥2 intracranialhemorrhages; f) combination of above.

3. There was a clear temporal relationship between a vascular event and onset ofcognitive deficit, cognitive impairment should appear within 3 months after a stroke,or abrupt deterioration, or stepwise progression of deficits; or cognitive impairmentmay be related to vascular factors, the Hachinski Ischemia scale (HIS) score ≥7;

4. And the patients must have adequate vision and hearing to participate in studyassessments;

5. Have a stable caregiver;

6. Can read simple articles and write simple sentences;

7. Informed consent, signed informed consent by legal guardian.

Exclusion Criteria:

1. Evidence of other reasons caused cognitive impairment, like Alzheimer disease,frontotemporal dementia, Parkinson disease dementia, dementia with Lewy bodies,Huntington disease, etc;

2. Subdural hematoma, traffic hydrocephalus, brain tumor, thyroid disease, vitamindeficiency, or other diseases which can lead to cognitive impairment;

3. Major depression (Hamilton depression rating scale [HAMD] ≥17) or other mentaldisorders ;

4. History of drug or alcohol abuse in the past 6 month;

5. History of epilepsy;

6. Patients with myasthenia gravis;

7. Subject cannot complete related test due to severe neurologic deficits;

8. Other uncontrolled chronic illnesses, like severe cardiovascular disease (severearrhythmia, myocardial infarction within 3 months, severe heart failure(New York HeartAssociation Functional Classification III and IV,); uncontrolled hypertension,diabetes);

9. Severe liver or kidney dysfunction (alanine aminotransferase or aspartate transaminasewas more than 1.5 times the upper limit of normal, or serum creatinine was more thanthe upper limit of normal);

10. Concomitant use of the anticonvulsants, antipsychotics, cholinomimetic drugs,anticholinergic agents, anti-Parkinson drugs, cholinesterase inhibitors, memantine,nootropic drug, nimodipine, anticholinergic or anticholinergic antidepressant oranxiolytic and other cognition enhancers within 1 month;

11. Severe asthma and chronic obstructive pulmonary disease;

12. Patients with severe indigestion, gastrointestinal obstruction, gastric or duodenalulcers;

13. Patients with glaucoma;

14. History of hypersensitivity to the treatment drugs;

15. Participate in other clinical study.