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

Not Applicable

• Conditions: Mild Cognitive Impairment
• Interventions: Drug: Aspirin; Drug: Cilostazol

• Registration Number: NCT01872858
• Lead Sponsor: Huashan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Primary Completion: 2012-11
• Status Verified: 2013-06
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-05
• Last Update Submitted: 2013-06-05
• Study First Posted: 2013-06-07
• Last Update Posted: 2013-06-07
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin	Aspirin	Aspirin, 100mg, Q.D, p.o, 2yr
Cilostazol	Cilostazol	cilostazol, 100mg, B.I.D, p.o, 2yr

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dept. of Neurology, Huashan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China