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

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 Overview

• Status: Unknown
• Conditions: Mild Cognitive Impairment
• Intervention / Treatment: Drug: Aspirin; Drug: Cilostazol

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Aspirin; Aspirin, 100mg, Q.D, p.o, 2yr	Drug: Aspirin; Aspirin, 100mg, Q.D, p.o, 2yr
Experimental: Cilostazol; cilostazol, 100mg, B.I.D, p.o, 2yr	Drug: Cilostazol; cilostazol, 100mg, B.I.D, p.o, 2yr

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Incident cerebral vascular event	including cerebral infarct, cerebral hemorrhage, transient ischemic attack.	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.	baseline, 2year
The progression of cerebral white matter lesion and lacunar infarction		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) .	baseline, 2year

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): November 1, 2012
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: June 5, 2013
• First Submitted That Met QC Criteria: June 5, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Estimate): June 7, 2013
• Last Update Submitted That Met QC Criteria: June 5, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Antipyretics; Neuroprotective Agents; Protective Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Phosphodiesterase Inhibitors; Phosphodiesterase 3 Inhibitors; Aspirin; Cilostazol
• Other Study ID Numbers: jianhuifu2013