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

Primary Purpose

Mild Cognitive Impairment

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Aspirin

Cilostazol

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Dept. of Neurology, Huashan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Aspirin

Cilostazol

Arm Description

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

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

Outcomes

Primary Outcome Measures

changes in cognitive function

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

Secondary Outcome Measures

Number of Participants with Incident cerebral vascular event

including cerebral infarct, cerebral hemorrhage, transient ischemic attack.

Changes of peripheral inflammatory markers level

intercellular adhesion molecules(ICAM), thrombomodulin, tissue factor(TF), tissue factor plasma inhibitor，TFPI, etc.

The progression of cerebral white matter lesion and lacunar infarction

changes in MRI-diffused tension image(DTI)

cerebral volume , lacune infarct, white matter lesion, micro-bleed, apparent diffusion coefficient(ADC) .

Full Information

NCT ID

NCT01872858

First Posted

June 5, 2013

Last Updated

June 5, 2013

Sponsor

Huashan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01872858

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Unknown status

Study Start Date

November 2010 (undefined)

Primary Completion Date

November 2012 (Actual)

Study Completion Date

November 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild Cognitive Impairment

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Aspirin

Arm Type

Active Comparator

Arm Description

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

Arm Title

Cilostazol

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Aspirin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cilostazol

Intervention Description

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

Primary Outcome Measure Information:

Title

changes in cognitive function

Description

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 Outcome Measure Information:

Title

Number of Participants with Incident cerebral vascular event

Description

including cerebral infarct, cerebral hemorrhage, transient ischemic attack.

Time Frame

3month, 6month, 1year and 2year

Title

Changes of peripheral inflammatory markers level

Description

intercellular adhesion molecules(ICAM), thrombomodulin, tissue factor(TF), tissue factor plasma inhibitor，TFPI, etc.

Time Frame

baseline, 2year

Title

The progression of cerebral white matter lesion and lacunar infarction

Time Frame

baseline, 3month, 6month, 1year and 2year

Title

changes in MRI-diffused tension image(DTI)

Description

cerebral volume , lacune infarct, white matter lesion, micro-bleed, apparent diffusion coefficient(ADC) .

Time Frame

baseline, 2year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Facility Information:

Facility Name

Dept. of Neurology, Huashan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jie Tang

Phone

+8618818210880

tan11711@hotmail.com

12. IPD Sharing Statement

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

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