Retina is a Marker for Cerebrovascular Heath

Cerebral Small Vessel Diseases Clinical Trial

Official title:

Retinal Vasoreactivity is a Marker for Cerebral Small Vessel Disease Progression

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753970
• Other study ID #: 20-000087
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: February 9, 2021
• Est. completion date: June 2026

Study information

• Verified date: July 2023
• Source: Mayo Clinic
• Contact: Meredith McDonald
• Phone: 904-953-4200
• Email: mcdonald.meredith[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, observational nested pilot randomized controlled study to discover retinal biomarkers that would predict cerebral small vessel disease progression, and evaluate the safety/efficacy of cilostazols in slowing SVD progression. Twenty CADASIL, 40 sWMD, 20 lobar CMB, and 20 age-matched healthy controls from the Mayo Clinic Florida Familial Cerebrovascular Disease Registry and neurology clinic will be recruited. All participants will undergo OCTA retinal scan, MRI-BOLD brain scan, cognitive battery evaluation, and blood sample at baseline and a 12-month follow-up visit. Key outcome measures are: RVR, CVR, cognition, WMH volume, and CMB volume. The 40 patients diagnosed in the course of routine clinical care with sWMD will be randomized in 1:1 ratio to receive cilostazol 100mg bid (or 50 mg bid if taking medications known to affect metabolism of cilostazol) or no cilostazol, and followed for WMD progression, and secondarily for changes in cognition, RVR and CVR. Flow diagram below outlines the study design. Note that in addition to what is shown in the trial flow diagram, patients will have telephone visits between baseline and 12 month clinic visits biweekly for 3 months and then monthly thereafter. These visits will consist of a survey for adverse events and at the 1-, 3-, 6- and 9-month telephone visits patients will also get a modified Rankin scale assessment, a Six-item screener (cognitive assessment) and a PHQ-2 (depression screen).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CADASIL
• Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy
• Cerebral Microbleeding
• Cerebral Small Vessel Diseases
• Dementia, Multi-Infarct
• Leukoencephalopathies
• Sporadic White Matter Disease

Intervention

Drug:
• Cilostazol
Cilostazol 100mg BID

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	white matter disease volume	change in total white matter disease volume	1 year
Secondary	cognition	global Z-score and by cognitive domain	1 year
Secondary	stroke	ischemic stroke or hemorrhagic stroke	1 year
Secondary	cerebrovasoreactivity	change in blood oxygen level dependence (BOLD) per unit of end tidal PCO2 mmHg	1 year
Secondary	retinal vasoreactivity	change in retinal vessel density pre/post CO2 challenge	1 year

External Links

•   Mayo Clinic Clinical Trials