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

Mild Cognitive Impairment Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01872858
• Other study ID #: jianhuifu2013
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2013
• Last updated: June 5, 2013
• Start date: November 2010
• Est. completion date: November 2015

Study information

• Verified date: June 2013
• Source: Huashan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Science and Technology Commission of Shanghai Municipality
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT01862575

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 2015
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

Drug:
• Aspirin
Aspirin, 100mg, Q.D, p.o, 2yr
• Cilostazol
cilostazol, 100mg, B.I.D, p.o, 2yr

Locations

Country	Name	City	State
China	Dept. of Neurology, Huashan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Number of Participants with Incident cerebral vascular event	including cerebral infarct, cerebral hemorrhage, transient ischemic attack.	3month, 6month, 1year and 2year	Yes
Secondary	Changes of peripheral inflammatory markers level	intercellular adhesion molecules(ICAM), thrombomodulin, tissue factor(TF), tissue factor plasma inhibitor,TFPI, etc.	baseline, 2year	No
Secondary	The progression of cerebral white matter lesion and lacunar infarction		baseline, 3month, 6month, 1year and 2year	Yes
Secondary	changes in MRI-diffused tension image(DTI)	cerebral volume , lacune infarct, white matter lesion, micro-bleed, apparent diffusion coefficient(ADC) .	baseline, 2year	Yes