Efficacy and Safety of Butylphthalide Soft Capsule for the Treatment of Vascular Dementia

Inclusion Criteria:

• 1. Age ≥50 and ≤75, male or female.
• 2. The subjects must have completed primary school education or above, and be ableto complete the cognitive ability test and other tests required by the program.
• 3. Meet the vascular dementia diagnosis criteria specified in the Diagnostic andStatistical Manual of Mental Disorders - 5th Edition (DSM-V).
• 4. Meet the SIVD diagnosis criteria of Erkinjuntti.
• 5. MRI supports the existence of an ischemic cerebrovascular disease; Meet theNational Institute of Neurological Disorders and Stroke (NINDS-AIREN) imagingdiagnosis criteria; The lesion located between supra-tentorial and subcorticalareas; The maximum diameter of the infarction ≤30mm; The number of infarctions ≥3,and/or Fazekas score=2-3.
• 6. The patients need to be enrolled 3 months after the last stroke, if there is aclear history of stroke; otherwise meet other Criteria.

• 7.The subjects are suffering from mild or moderate vascular dementia, with 11≤ MMSE ≤26, and the Clinical Dementia Rating (CDR) score 1≤ CDR ≤2.

• 8. The Hamilton depression scale (HAMD) total score ≤17.
• 9. The patient agrees to participate in this study and the patient or his or herlegal guardian has signed the informed consent before the study.
• 10. The subjects must have a care giver who has completed primary school educationor above. The MMSE score of the care giver should be within the following range:education level of primary school > 20 points, education level above primary school > 24 points. And the care giver shall also be able to take care of the patient atleast 4 days a week for more than 4 hours a day while he or she can accompany thesubjects to attend each visit.

Exclusion Criteria:

• 1. Patients suffering from dementia caused by other cerebral diseases other than VaD (such as Alzheimer's disease, dementia with Lewy bodies, frontotemporal dementia,Parkinson's disease, demyelinating diseases of the central nervous system, tumors,hydrocephalus, traumas, syphilis, AIDS, Creutzfeldt-Jakob disease, etc.);
• 2. MRI indicates hippocampus or entorhinal cortex atrophy; and patients for whom VaDin combination with AD has been maximally excluded. But the following two cases canbe included: ① Those aged 70 years and above with MTA score of grade 2 can beincluded; ② Those with grade 3 white matter injury score can be included with MTAscore of grade 2.
• 3. Patients with severe neurologic impairments that hinder them from completing therequired tests, such as hemiplegia of the convenient hand, various kinds of aphasia,and audio or visual disorders.
• 4. Patients who cannot swallow any orally administered drugs, or who is sufferingfrom any disease that can affect the absorption of orally administered drugs, suchas active intestinal diseases, partial or complete intestinal obstruction.
• 5. Patients suffering from severe diseases of the circulation system, therespiration system, the urinary system, the digestive system and the hemopoieticsystem (such as unstable angina pectoris, uncontrollable asthma and active gastricbleeding) and cancer.
• 6. Patients suffering from nutritional and metabolic diseases and endocrine systemdisorders, such as thyroid disease, parathyroid disease and deficiency of vitamin orother elements.
• 7. Patients suffering from severe mental diseases (such as depression andschizophrenia) and epilepsy.
• 8. Patients with alcohol or drug abuse.
• 9. Patients with a family history of dementia.
• 10. Patients who have been given any drug that can affect the cognitive function,such as cholinergic drugs, antipsychotic drugs and nootropic agents (includingtraditional Chinese herbal medicines and pills, such as cholinesterase inhibitors,memantine, Cenma Yizhi Capsules and Jiannaoan), for a long period of time (within 3month before the start of this study and will continue using such drug).
• 11. Patients who have used Butylphthalide soft capsule or injection within 2 weeksbefore grouping.
• 12. Patients who are allergic to Butylphthalide/celery.
• 13. Patients with severe bleeding tendency or hepatic dysfunction (with transaminasehigher than 3 times of the normal upper limit).
• 14. Pregnant or breast feeding women.
• 15. Patients who have participated in other interference clinical studies within 3months before grouping.
• 16. Patients for whom MRI cranial imaging cannot be performed.