NCT00847860

Brief Summary

The purpose of this study is to evaluate the efficacy of PDE-3 inhibitor, cilostazol, in prevention and treatment of vascular dementia, in those with brain white matter lesions and vascular risk factors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2008

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

May 6, 2015

Status Verified

December 1, 2009

Enrollment Period

3.2 years

First QC Date

February 17, 2009

Last Update Submit

May 5, 2015

Conditions

Vascular DementiaStroke

Keywords

cognition

Outcome Measures

Primary Outcomes (1)

  • changes of the scores of MMSE, MOCA,CDR,and Blessed-Roth

    one year

Secondary Outcomes (1)

  • stroke recurrence, other vascular ischemic events, bleeding events

    one year

Study Arms (2)

1

EXPERIMENTAL

Cilostazol

Drug: Cilostazol

2

ACTIVE COMPARATOR

Asprin

Drug: Aspirin

Interventions

CilostazolDRUG

Cilostazol 100 mg bid for 12 months

1
AspirinDRUG

Aspirin 100 mg qd for 12 months

2

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ranging from 40 to 80 years
  • After newly ischemic stroke from 3 months to 2 years
  • Brain CT or MRI shows stroke lesions and white matter lesions, ARWMC(Age Related White Matter Change)\>=4
  • Moderate or mild cognitive deficits: MMSE 12-26
  • Vascular or mixed dementia: Hachinski ischemic score\>4
  • Moderate or mild disability: MRS\<=4,NIHSS\<20
  • Informed consent

You may not qualify if:

  • Definitive diagnosis of dementia prior to the stroke
  • Cerebral hemorrhage in the past
  • Cerebral embolism result from cardiogenic embolus
  • Critically ills: MRS\>4,NIHSS\>=20
  • Bed-ridden patient who is hardly discovered newly stroke
  • patient with sever cardiac, hepatic or nephric complication
  • dementia caused not by vascular lesions
  • other diseases disturb the cognitive evaluation
  • susceptibility to varieties of allergen
  • abstain from Cilostazol or Asprin
  • antiplatelet treatment, anticoagulation or fibrinolysis are needed because of other diseases
  • rejected to participate by the patient or the family

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Shanghai Hua Shan Hospital

Shanghai, Shanghai Municipality, 200040, China

Location

Related Publications (1)

  • Kwan J, Hafdi M, Chiang LLW, Myint PK, Wong LS, Quinn TJ. Antithrombotic therapy to prevent cognitive decline in people with small vessel disease on neuroimaging but without dementia. Cochrane Database Syst Rev. 2022 Jul 14;7(7):CD012269. doi: 10.1002/14651858.CD012269.pub2.

    PMID: 35833913DERIVED

MeSH Terms

Conditions

Dementia, VascularStroke

Interventions

CilostazolAspirin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesIntracranial ArteriosclerosisIntracranial Arterial DiseasesDementiaLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Huang Yining, MD PhD

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 17, 2009

First Posted

February 19, 2009

Study Start

March 1, 2008

Primary Completion

May 1, 2011

Study Completion

June 1, 2011

Last Updated

May 6, 2015

Record last verified: 2009-12

Locations

CN(2)