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

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ClinicalTrials.gov Identifier: NCT01872858
Recruitment Status : Unknown
Verified June 2013 by Jianhui Fu, Huashan Hospital.
Recruitment status was:  Recruiting
First Posted : June 7, 2013
Last Update Posted : June 7, 2013
Sponsor:
Information provided by (Responsible Party):
Jianhui Fu, 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.

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: Aspirin Drug: Cilostazol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2010
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

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




Primary Outcome Measures :
  1. changes in cognitive function [ Time Frame: 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 :
  1. Number of Participants with Incident cerebral vascular event [ Time Frame: 3month, 6month, 1year and 2year ]
    including cerebral infarct, cerebral hemorrhage, transient ischemic attack.

  2. Changes of peripheral inflammatory markers level [ Time Frame: baseline, 2year ]
    intercellular adhesion molecules(ICAM), thrombomodulin, tissue factor(TF), tissue factor plasma inhibitor,TFPI, etc.

  3. The progression of cerebral white matter lesion and lacunar infarction [ Time Frame: baseline, 3month, 6month, 1year and 2year ]
  4. changes in MRI-diffused tension image(DTI) [ Time Frame: baseline, 2year ]
    cerebral volume , lacune infarct, white matter lesion, micro-bleed, apparent diffusion coefficient(ADC) .



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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872858


Locations
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China, Shanghai
Dept. of Neurology, Huashan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Jie Tang    +8618818210880    tan11711@hotmail.com   
Sponsors and Collaborators
Huashan Hospital

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Responsible Party: Jianhui Fu, Department of Neurology, Huashan Hospital, Huashan Hospital
ClinicalTrials.gov Identifier: NCT01872858     History of Changes
Obsolete Identifiers: NCT01862575
Other Study ID Numbers: jianhuifu2013
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: June 7, 2013
Last Verified: June 2013

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