A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCenter for Clinical Studies, Texas

About this trial

The purpose of this observational research study is to study if patients with herpes zoster, also known as Shingles, have a higher risk of vascular dysfunction (problems with blood vessels, including stroke) and vascular dementia (problems with mental decline as a result of decreased blood flow to the brain) compared to patients without herpes zoster.

Patients are evaluated based on the group they are assigned too:

1. Herpes Zoster (HZ) Group: individuals presenting with untreated herpes zoster. These participants will have 6 visits:

* Day 1 = 1st day presenting to clinic with acute zoster * 7 days post zoster * 1 month after Day 1 * 3 months after Day 1 * 6 months after Day 1 * 12 months after Day 1 2. Control Group: individuals without herpes zoster o Day 1 (only 1 visit will be completed)

This study does not have a study medication/device. Standard of care for all patients will be followed.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Be a male or female ≥ 18 years of age.

Present to clinic for routine dermatologic evaluation with or without rash.

Are willing and able to complete study visits and procedures, and able to effectively communicate with the investigator and other study personnel.

Have adequate venous access and are willing to undergo venipuncture for blood draws.

Disqualifiers

Female individuals who are pregnant or breast-feeding.

Receiving systemic or topical antivirals for varicella zoster virus (VZV).

Sensitivity or allergy to systemic or topical antiviral medications for HZ.

History of diagnosed HZ within the last 8 years.

Trial population

Each year, 50 control subjects and 25 zoster individuals will be recruited to provide blood samples for this study, as well as clinical and laboratory information. This study will recruit individuals reflective of the United States demographics: 58% white (non-Hispanic), 19% Hispanic, 12% Black/African American, 6% Asian, and 5% two or more races. Houston is the fourth most populous city in the United States and has a demographic breakdown and population pool conducive to reflect the United States population. We will aim to recruit the following annually for years 1-5: (1) of the 50 control subjects, 29 White (non-Hispanic), 10 Hispanic, 6 Black/African American, 3 Asian, 2 Other (two or more), and (2) of the 25 control subjects, 14 White (non-Hispanic), 5 Hispanic, 3 Black/African American, 2 Asian, 1 Other (two or more). Within each ethnic group, half will be women and half men.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

375 Participants
are grouped into 2 trial groups
Group A: HZ (Herpes Zoster) Group
Group B: Control Group

Trial outcomes

Primary outcomes

1

Analyze exosome content for known vascular damaging proteins/miRNAs from matched control and HZ individuals over a 12-month period.

Using mass spectrometry and small RNA sequencing, we will quantify abundance and temporal changes of exosomal proteins and miRNAs associated with vascular dysfunction, inflammation, coagulation, and stroke, then correlate analytes with clinical and laboratory features (anti-VZV IgG titers and IgM, complete blood counts, comprehensive metabolic panel, and aPTT/PT/INR). Enrichment analyses will be conducted on the network of exosomal proteins and miRNAs to uncover pathways and shared analytes associated with HZ, vascular dysfunction, and neurodegenerative processes.

Time frame
From enrollment throughout the 5-year proposal period, occurring in a cyclical and overlapping manner.

Secondary outcomes

1

Determine the mechanism(s) in which non-infectious HZ exosomes promote vascular dysfunction.

Time frame
From enrollment throughout the 5-year proposal period, occurring in a cyclical and overlapping manner.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Center for Clinical Studies, Texas

Lead sponsor

National Institute on Aging (NIA)

Collaborator