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

NCT01872858 | Unknown

• 1 other identifier: jianhuifu2013
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Number of Participants with Incident cerebral vascular event

  3month, 6month, 1year and 2year

• Changes of peripheral inflammatory markers level

  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)

  baseline, 2year

Study Arms (2)

Aspirin

ACTIVE COMPARATOR

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

Drug: Aspirin

Cilostazol

EXPERIMENTAL

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

Drug: Cilostazol

Interventions

Aspirin DRUG

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

Aspirin

Cilostazol DRUG

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

Cilostazol

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Dept. of Neurology, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Aspirin; Cilostazol

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Neurology, Huashan Hospital

Study Record Dates

• First Submitted: June 5, 2013
• First Posted: June 7, 2013
• Study Start: November 1, 2010
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2015
• Last Updated: June 7, 2013

Record last verified: 2013-06

Locations

CN (1)