Efficacy and Safety of Cilostazol in Patients of Vascular Cognitive Impairment-no Dementia (VCIND)

Study Overview
=================
Brief Summary
-----------------
Patients of vascular cognitive impairment-no dementia (VCIND) in one group is prescribed cilostazol,in the other group is prescribed aspirin. Evaluate both of them in cognitive function, MRI and other sides at given time. The investigators hypothesize that cilostazol is more efficient and safer than aspirin in patients with VCIND.

Conditions
-----------------
Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Drug: Aspirin
* Drug: Cilostazol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged between 50-80, both gender； Small vessel disease and associated cognitive impairment, diagnosed as VCIND； Non-specific subjective symptoms (dizziness, somnolence, numbness in limbs) are acceptable. Normal hepatic and renal function. With good compliance. Exclusion Criteria: Aged above 80 or less than 50. Dementia. Cerebral infarction(>2cm). Major vascular lesion. (stenosis>50%). Cardiac cerebral infarction. Intracerebral Hemorrhage. Clinical manifestations cannot attribute to small vessel disease. Major depression or dysfunction in speech, visual ability, hearing or aphasia that would interfere with the cognitive assessment. Severe systematic organic impairment(cardiac, hepatic, renal dysfunction). Thrombocytopenic Purpura. History of hemorrhage in digestive system or surgery in past 3 months. Previously on cilostazol treatment for more than 3 month. Allergic to aspirin or cilostazol. Enrolled in other clinical trials in past 3 months. Lack of informed consent or compliance. Contraindications for MRI scan.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aspirin<br>Aspirin, 100mg, Q.D, p.o, 2yr | Drug: Aspirin<br>* Aspirin, 100mg, Q.D, p.o, 2yr<br>|
| Experimental: Cilostazol<br>cilostazol, 100mg, B.I.D, p.o, 2yr | Drug: Cilostazol<br>* cilostazol, 100mg, B.I.D, p.o, 2yr<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in cognitive function | scores in Montreal Cognitive Assessment，Mini-Mental Status Examination, Clinal Dementia Rating，trail making test, similarity test, Stroop test. | baseline, 3month, 6month, 1year, and 2year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Incident cerebral vascular event | including cerebral infarct, cerebral hemorrhage, transient ischemic attack. | 3month, 6month, 1year and 2year | 
| Changes of peripheral inflammatory markers level | intercellular adhesion molecules(ICAM), thrombomodulin, tissue factor(TF), tissue factor plasma inhibitor，TFPI, etc. | baseline, 2year | 
| The progression of cerebral white matter lesion and lacunar infarction |  | baseline, 3month, 6month, 1year and 2year | 
| changes in MRI-diffused tension image(DTI) | cerebral volume , lacune infarct, white matter lesion, micro-bleed, apparent diffusion coefficient(ADC) . | baseline, 2year |