Mild Cognitive ImpairmentNCT01872858
Efficacy and Safety of Cilostazol in Patients of Vascular Cognitive Impairment-no Dementia (VCIND)
A study testing Aspirin and Cilostazol in people with Mild Cognitive Impairment, run by Huashan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Aspirin and Cilostazol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Aged above 80 or less than 50.
- Dementia.
- Cerebral infarction(>2cm).
- Major vascular lesion. (stenosis>50%).
- Cardiac cerebral infarction.
- Intracerebral Hemorrhage.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dept. of Neurology, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
Jie Tang, +8618818210880, tan11711@hotmail.com
About this study
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
- Being tested
- Aspirin, Cilostazol
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin, 100mg, Q.D, p.o, 2yr
CilostazolDrug
cilostazol, 100mg, B.I.D, p.o, 2yr
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Active comparator | Aspirin, 100mg, Q.D, p.o, 2yr Receives: Drug: Aspirin |
| Cilostazol | Experimental | cilostazol, 100mg, B.I.D, p.o, 2yr Receives: Drug: Cilostazol |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in cognitive function
scores in Montreal Cognitive Assessment，Mini-Mental Status Examination, Clinal Dementia Rating，trail making test, similarity test, Stroop test.
Measured: baseline, 3month, 6month, 1year, and 2year
Secondary outcomes (4)
Number of Participants with Incident cerebral vascular event
including cerebral infarct, cerebral hemorrhage, transient ischemic attack.
Measured: 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.
Measured: baseline, 2year
The progression of cerebral white matter lesion and lacunar infarction
Measured: 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) .
Measured: baseline, 2year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startNov 2010
- Primary completionNov 2012
- Study completionNov 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianhui Fu, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872858
- Sponsor's protocol ID
- jianhuifu2013
- Status last verified
- Jun 2013
- First submitted
- 5 Jun 2013
- Last updated
- 7 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cilostazol in Patients of Vascular Cognitive Impairment-no Dementia (VCIND)
- ClinicalTrials.gov ID
- NCT01872858
- Acronym / sponsor ID
- jianhuifu2013
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2015 (estimated)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Active comparator | Drug: AspirinAspirin, 100mg, Q.D, p.o, 2yr |
| Cilostazol | Experimental | Drug: Cilostazolcilostazol, 100mg, B.I.D, p.o, 2yr |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- Aged above 80 or less than 50.
- Dementia.
- Cerebral infarction(>2cm).
- Major vascular lesion. (stenosis>50%).
- Cardiac cerebral infarction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAspirin, 100mg, Q.D, p.o, 2yr | Drug | Aspirin |
| Cilostazolcilostazol, 100mg, B.I.D, p.o, 2yr | Drug | Cilostazol |
Primary outcome
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.
4 secondary outcomes
Number of Participants with Incident cerebral vascular event
Time frame: 3month, 6month, 1year and 2year
Changes of peripheral inflammatory markers level
Time frame: baseline, 2year
The progression of cerebral white matter lesion and lacunar infarction
Time frame: baseline, 3month, 6month, 1year and 2year
changes in MRI-diffused tension image(DTI)
Time frame: baseline, 2year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dept. of Neurology, Huashan Hospital, Fudan University
Shanghai, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin and Cilostazol in people with Mild Cognitive Impairment, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in cognitive function (time frame: baseline, 3month, 6month, 1year, and 2year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2013.