Recruiting
Phase 1
Phase 2

Cilostazol

Sponsor:

Mayo Clinic

Code:

NCT04753970

Conditions

Cerebral Small Vessel Diseases

Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy

Cerebral Microbleeding

Sporadic White Matter Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cilostazol

Study Details

Brief summary:

Cerebral small vessel disease (SVD), present in 80-94% of adults over age 65 years, increases the risk of stroke by 2-fold, and dementia by 2.3-fold. There is currently no treatment to slow SVD progression. This study aims to test whether impaired cerebral and retinal vasoreactivity may serve as biomarker for SVD progression, and to evaluate the safety and efficacy of cilostazol (antiplatelet agent with vasodilatory and anti-inflammatory properties) for the treatment of SVD.

Conditions

Cerebral Small Vessel Diseases

Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy

Cerebral Microbleeding

Sporadic White Matter Disease

Study ID

NCT04753970

Start date

Feb 9, 2021

Status verified date

Jul, 2026

Completion date

Jun, 2030

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age ≥18 yo.
  • Diagnosis of CADASIL, sporadic WMD or lobar CMB and age-matched healthy controls (eg. patient's spouse or unrelated friends without SVD)

Exclusion Criteria:

  • Age<18yo
  • Pregnant
  • Breast feeding
  • Unable to follow commands
  • Unable to tolerate MRI

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Cilostazol

Cilostazol 100mg BID

no intervention: No intervention

Interventions

Cilostazol

Cilostazol 100mg BID

Primary outcome measure

  • white matter disease volume [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Meredith McDonald

904-953-4200mcdonald.meredith@mayo.edu

Locations

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Meredith McDonald

904-953-4200mcdonald.meredith@mayo.edu

More Information

Sponsor

Mayo Clinic

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-08-03.