Retina is a Marker for Cerebrovascular Heath

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Age<18yo

Pregnant

Breast feeding

Unable to follow commands

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cilostazol

    Drug

    Cilostazol 100mg BID

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: CilostazolExperimental treatment 1 intervention
Group B: No interventionNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

white matter disease volume

change in total white matter disease volume

Time frame
1 year

Secondary outcomes

1

cognition

global Z-score and by cognitive domain

Time frame
1 year
2

stroke

ischemic stroke or hemorrhagic stroke

Time frame
1 year
3

cerebrovasoreactivity

change in blood oxygen level dependence (BOLD) per unit of end tidal PCO2 mmHg

Time frame
1 year
4

retinal vasoreactivity

change in retinal vessel density pre/post CO2 challenge

Time frame
1 year

Other outcomes

Sponsors and contacts

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