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

Launched by CENTER FOR CLINICAL STUDIES, TEXAS · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is looking to understand if people who have shingles (also known as herpes zoster) are at a higher risk of developing problems with their blood vessels, which could lead to conditions like stroke or vascular dementia (a type of memory decline caused by poor blood flow to the brain). The study will compare two groups: one group of individuals who currently have shingles and another group who do not have shingles. Participants in the shingles group will have several visits over a year to monitor their health, while those in the control group will only have one visit.

To be eligible for the study, participants must be at least 18 years old and willing to complete the required visits. Specifically, those in the shingles group need to show up with active shingles that hasn't been treated with antiviral medications. Participants will not receive any study medications or treatments, but they will receive standard care for their condition. It's important to note that certain individuals, such as those who are pregnant, have had shingles recently, or have specific health issues, will not be able to join the trial. Overall, this research aims to gain valuable insights into the connection between shingles and blood vessel health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• At the Screening Visit (Visit 1/Day 1), all participants must meet all the following criteria in order to be considered for participation in the study:
• • 1. Be a male or female ≥ 18 years of age.
• • 2. Present to clinic for routine dermatologic evaluation with or without rash.
• • 3. Are willing and able to complete study visits and procedures, and able to effectively communicate with the investigator and other study personnel.
• • 4. Have adequate venous access and are willing to undergo venipuncture for blood draws.
• • 5. Able to provide written informed consent prior to any study procedures. Additional inclusion criteria for Herpes zoster (HZ) participants,
• • 6. Present with acute, vesicle-stage HZ that has not been treated with antiviral therapies
• • 7. Are willing and have reliable transportation to complete additional follow-up visits at 7 days, 1 month, 3 months, 6 months, and 12 months after initial visit for acute HZ.
• Exclusion Criteria:
• At the Screening Visit (Visit 1/Day 1), participants meeting any of the following criteria will be excluded from participation in the study:
• • 1. Female individuals who are pregnant or breast-feeding.
• • 2. Receiving systemic or topical antivirals for varicella zoster virus (VZV).
• • 3. Sensitivity or allergy to systemic or topical antiviral medications for HZ.
• • 4. History of diagnosed HZ within the last 8 years.
• • 5. Received a HZ vaccine (e.g., Zostavax®/Shingrix®) within the last 8 years.
• • 6. Received any vaccinations within the last 3 months.
• • 7. Currently taking immunosuppressive therapies, including medications and radiation.
• • 8. Currently taking any anticoagulants.
• • 9. History of any coagulation disorder(s).
• • 10. History of end-stage renal disease or uremia.
• • 11. History of end-stage liver disease.
• • 12. History of HIV.
• • 13. Have had a COVID-19 infection in last 3 months.
• • 14. Any history of non-skin cancers within the last 3 months.
• • 15. History of serious infection requiring hospitalization in the last 3 months.
• • 16. Prior history of cardiovascular accident or myocardial infarction within the last 12 months.
• • 17. Prior cerebrovascular accident in the past 12 months.