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

Huashan Hospital200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Mild Cognitive Impairment

Interventions

AspirinDRUG

Aspirin, 100mg, Q.D, p.o, 2yr

CilostazolDRUG

cilostazol, 100mg, B.I.D, p.o, 2yr

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged between 50-80, both gender； 2. Small vessel disease and associated cognitive impairment, diagnosed as VCIND； 3. Non-specific subjective symptoms (dizziness, somnolence, numbness in limbs) are acceptable. 4. Normal hepatic and renal function. 5. With good compliance. Exclusion Criteria: 1. Aged above 80 or less than 50. 2. Dementia. 3. Cerebral infarction(\>2cm). 4. Major vascular lesion. (stenosis\>50%). 5. Cardiac cerebral infarction. 6. Intracerebral Hemorrhage. 7. Clinical manifestations cannot attribute to small vessel disease. 8. Major depression or dysfunction in speech, visual ability, hearing or aphasia that would interfere with the cognitive assessment. 9. Severe systematic organic impairment(cardiac, hepatic, renal dysfunction). 10. Thrombocytopenic Purpura. 11. History of hemorrhage in digestive system or surgery in past 3 months. 12. Previously on cilostazol treatment for more than 3 month. 13. Allergic to aspirin or cilostazol. 14. Enrolled in other clinical trials in past 3 months. 15. Lack of informed consent or compliance. 16. Contraindications for MRI scan.

Locations (1)

Dept. of Neurology, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

changes in cognitive function

scores in Montreal Cognitive Assessment，Mini-Mental Status Examination, Clinal Dementia Rating，trail making test, similarity test, Stroop test.

Time frame: baseline, 3month, 6month, 1year, and 2year

Secondary Outcomes

Number of Participants with Incident cerebral vascular event

including cerebral infarct, cerebral hemorrhage, transient ischemic attack.

Time frame: 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.

Time frame: baseline, 2year

The progression of cerebral white matter lesion and lacunar infarction

Time frame: 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) .

Time frame: baseline, 2year

Data from ClinicalTrials.gov

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