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

Information source: Huashan Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mild Cognitive Impairment

Intervention: Aspirin (Drug); Cilostazol (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Huashan Hospital

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.

Clinical Details

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: changes in cognitive function

Secondary outcome:

Number of Participants with Incident cerebral vascular event

Changes of peripheral inflammatory markers level

The progression of cerebral white matter lesion and lacunar infarction

changes in MRI-diffused tension image(DTI)

Eligibility

Minimum age: 50 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

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 and Contacts

Dept. of Neurology, Huashan Hospital, Fudan University, Shanghai, Shanghai 200040, China; Recruiting
Jie Tang, Phone: +8618818210880, Email: tan11711@hotmail.com
Additional Information

Starting date: November 2010
Last updated: June 5, 2013

Page last updated: August 23, 2015

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