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 followingrange: education level of primary school > 20 points, education level aboveprimary school > 24 points. And the care giver shall also be able to take careof the patient at least 4 days a week for more than 4 hours a day while he orshe can accompany the subjects to attend each visit.

Exclusion Criteria:

1. Patients suffering from dementia caused by other cerebral diseases other thanVaD (such as Alzheimer's disease, dementia with Lewy bodies, frontotemporaldementia, Parkinson's disease, demyelinating diseases of the central nervoussystem, tumors, hydrocephalus, traumas, syphilis, AIDS, Creutzfeldt-Jakobdisease, etc.);

2. MRI indicates hippocampus or entorhinal cortex atrophy; and patients for whomVaD in combination with AD has been maximally excluded. But the following twocases can be included: ① Those aged 70 years and above with MTA score of grade 2 can be included; ② Those with grade 3 white matter injury score can beincluded with MTA score of grade 2.

3. Patients with severe neurologic impairments that hinder them from completingthe required tests, such as hemiplegia of the convenient hand, various kinds ofaphasia, 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,such as 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 thehemopoietic system (such as unstable angina pectoris, uncontrollable asthma andactive gastric bleeding) and cancer.

6. Patients suffering from nutritional and metabolic diseases and endocrine systemdisorders, such as thyroid disease, parathyroid disease and deficiency ofvitamin or other 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 cholinesteraseinhibitors, memantine, Cenma Yizhi Capsules and Jiannaoan), for a long periodof time (within 3 month before the start of this study and will continue usingsuch 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 (withtransaminase higher 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.