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RECRUITING

NCT06903078

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

Sponsor: Center for Clinical Studies, Texas

View on ClinicalTrials.gov

Summary

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.

Official title: Pathogenic Exosomes During Herpes Zoster Mediate Increased Vascular Dementia Risk.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

375

Start Date

2025-02-13

Completion Date

2030-08

Last Updated

2025-12-11

Healthy Volunteers

Yes

Conditions

Herpes Zoster (HZ)Vascular Dementia

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.

Locations (2)

Center for Clinical Studies, LTD. LLP

Houston, Texas, United States