A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.
Center for Clinical Studies, Texas · with National Institute on Aging (NIA) · NCT06903078
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 375
- US sites recruiting
- 2
- Study start
- February 13, 2025
- Record last updated
- December 11, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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:
- 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
- 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.
Conditions: Herpes Zoster (HZ); Vascular Dementia
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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:
- 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 Criteria
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.
Recruiting US locations
Center for Clinical Studies, LTD. LLP
Houston, TX 77004
Site contact: Stephen K. Tyring, MD · 713-528-8818 · info@ccstexas.com
Center for Clinical Studies, LTD. LLP
Webster, TX 77598
Site contact: Stephen K. Tyring, MD · 281-333-2288 · info@ccstexas.com
Study contacts (from the official record)
- Study Principal Investigator · 281-333-2288 · info@ccstexas.com
- Director of Research · 281-333-2288 · dyetman@ccstexas.com
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