Retina is a Marker for Cerebrovascular Heath
Retinal Vasoreactivity is a Marker for Cerebral Small Vessel Disease Progression
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2021
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2021
CompletedStudy Start
First participant enrolled
February 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
July 23, 2025
July 1, 2025
5.3 years
February 9, 2021
July 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
white matter disease volume
change in total white matter disease volume
1 year
Secondary Outcomes (4)
cognition
1 year
stroke
1 year
cerebrovasoreactivity
1 year
retinal vasoreactivity
1 year
Study Arms (2)
Cilostazol
EXPERIMENTALCilostazol 100mg BID
No intervention
NO INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Age\<18yo
- Pregnant
- Breast feeding
- Unable to follow commands
- Unable to tolerate MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle P Lin, MD, MPH
Mayo Clinic
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 9, 2021
First Posted
February 15, 2021
Study Start
February 9, 2021
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share