Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID06903078

Pathogenic Exosomes During Herpes Zoster Mediate Increased Vascular Dementia Risk

Led by Center for Clinical Studies, Texas · Updated on 2025-12-11

375

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

Sponsors

C

Center for Clinical Studies, Texas

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating whether people with herpes zoster, also known as shingles, have a higher risk of blood vessel problems, including stroke, and vascular dementia compared to those without herpes zoster. The study focuses on understanding how exosomes, small particles in the blood, might contribute to these risks by promoting inflammation and clotting, which can affect brain blood flow. This observational research aims to clarify how herpes zoster could lead to vascular dementia and stroke over time. Participants are divided into two groups: those with untreated acute herpes zoster and those without herpes zoster. The herpes zoster group will have six visits over a year, starting from the first day of rash appearance and continuing at 7 days, 1 month, 3 months, 6 months, and 12 months after. The control group will have a single visit. No study medications or devices are given; all participants receive standard care. During the visits, the study collects data and blood samples to analyze exosome content and how it affects cells involved in blood vessel function. Researchers will measure proteins and genetic material in exosomes linked to vascular damage and monitor inflammatory responses. They will also assess platelet activation, blood vessel cell health, and the risk of stroke or vascular events. The primary goal is to understand the mechanisms behind increased vascular dementia risk in herpes zoster patients over a 12-month period.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Be male or female aged 18 years or older
  • Present to clinic for routine dermatologic evaluation with or without rash
  • Willing and able to complete study visits and procedures
  • Have adequate venous access and willing to undergo blood draws
  • Able to provide written informed consent
  • For herpes zoster group: have acute, vesicle-stage herpes zoster not treated with antivirals
  • Willing and able to attend follow-up visits at 7 days, 1, 3, 6, and 12 months after initial visit
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding females
  • Receiving systemic or topical antivirals for varicella zoster virus
  • Allergic or sensitive to antiviral medications for herpes zoster
  • History of herpes zoster diagnosed within last 8 years
  • Received herpes zoster vaccine within last 8 years
  • Received any vaccinations within last 3 months
  • Currently on immunosuppressive therapies or radiation
  • Currently taking anticoagulants
  • History of coagulation disorders
  • History of end-stage renal disease or uremia
  • History of end-stage liver disease
  • History of HIV infection
  • Had COVID-19 infection in last 3 months
  • History of non-skin cancers within last 3 months
  • History of serious infection requiring hospitalization in last 3 months
  • Prior stroke or myocardial infarction within last 12 months
  • Prior cerebrovascular accident within last 12 months

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Enrollment and Baseline Assessment

Duration - 1 day

Participants with acute herpes zoster or controls provide baseline data and biospecimens to analyze vascular damaging exosome content.

1 visit (in-person)

Longitudinal Monitoring and Sample Collection

Duration - 12 months

Participants attend follow-up visits over 12 months to provide blood samples and data for analysis of exosome content and vascular dysfunction mechanisms.

5 follow-up visits at 7 days, 1 month, 3 months, 6 months, and 12 months (in-person)

Trial Site Locations

Total: 2 locations

1

Center for Clinical Studies, LTD. LLP

Houston, Texas, United States, 77004

Actively Recruiting

2

Center for Clinical Studies, LTD. LLP

Webster, Texas, United States, 77598

Actively Recruiting

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Research Team

S

Study Principal Investigator

D

Director of Research

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Published Research Related To This Trial

Distribution of herpes simplex virus type 1 and varicella zoster virus in ganglia of the human head and neck.

Elizabeth R Richter, James K Dias, James E Gilbert...

https://pubmed.ncbi.nlm.nih.gov/19919304