A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.
Recruiting now
Conditions studied: Herpes Zoster (HZ), Vascular Dementia
In brief
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.
Key facts
- Study ID
- NCT06903078
- Run by
- Center for Clinical Studies, Texas
- People needed
- 375
- Starts
- 2025-02-13
- Expected to finish
- 2030-08-01
- Last updated by the study team
- 2025-12-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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:
- 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.
- Able to provide written informed consent prior to any study procedures. Additional inclusion criteria for Herpes zoster (HZ) participants,
- Present with acute, vesicle-stage HZ that has not been treated with antiviral therapies
- 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.
You may not qualify if…
- At the Screening Visit (Visit 1/Day 1), participants meeting any of the following criteria will be excluded from participation in the study:
- 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.
- Received a HZ vaccine (e.g., Zostavax®/Shingrix®) within the last 8 years.
- Received any vaccinations within the last 3 months.
- Currently taking immunosuppressive therapies, including medications and radiation.
- Currently taking any anticoagulants.
- History of any coagulation disorder(s).
- History of end-stage renal disease or uremia.
- History of end-stage liver disease.
- History of HIV.
- Have had a COVID-19 infection in last 3 months.
- Any history of non-skin cancers within the last 3 months.
- History of serious infection requiring hospitalization in the last 3 months.
- Prior history of cardiovascular accident or myocardial infarction within the last 12 months.
- Prior cerebrovascular accident in the past 12 months.
Where it is running
- Center for Clinical Studies, LTD. LLP — Houston, Texas, United States (enrolling)
- Center for Clinical Studies, LTD. LLP — Webster, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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