Status:
RECRUITING
A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.
Lead Sponsor:
Center for Clinical Studies, Texas
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Herpes Zoster (HZ)
Vascular Dementia
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
Vascular dementia: Vascular dementia is the second most common form of dementia after Alzheimer's disease and is characterized broadly as a loss of blood supply to the brain and compromised blood-brai...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 13 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT06903078
Start Date
February 13 2025
End Date
August 1 2030
Last Update
December 11 2025
Active Locations (2)
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1
Center for Clinical Studies, LTD. LLP
Houston, Texas, United States, 77004
2
Center for Clinical Studies, LTD. LLP
Webster, Texas, United States, 77598