Analyzing the link between shingles and vascular dementia risk

Pathogenic Exosomes During Herpes Zoster Mediate Increased Vascular Dementia Risk.

This study is trying to see if having shingles increases the risk of developing problems with blood vessels and vascular dementia compared to people who don't have shingles.

Quick facts

• Study type: Observational
• Enrollment: 375 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Center for Clinical Studies, Texas (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (Houston, Texas and 1 other locations)
• Trial ID: NCT06903078 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate whether individuals with herpes zoster (shingles) have an increased risk of vascular dysfunction and vascular dementia compared to those without the condition. Participants with untreated herpes zoster will undergo a series of six follow-up visits over a year, while a control group without herpes zoster will complete only one visit. The study will collect participant data and biospecimens to analyze the role of pathogenic exosomes in mediating these risks. Standard care will be provided to all participants throughout the study.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older presenting with untreated herpes zoster.

Not a fit: Patients who have previously received antiviral treatment for herpes zoster or do not have the condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and prevention strategies for vascular dementia in patients with herpes zoster.

How similar studies have performed: While the specific link between herpes zoster and vascular dementia is being explored, similar studies have indicated that viral infections can influence vascular health, suggesting potential for success.

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.

Where this trial is running

Houston, Texas and 1 other locations

• Center for Clinical Studies, LTD. LLP — Houston, Texas, United States (Recruiting)
• Center for Clinical Studies, LTD. LLP — Webster, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Study Principal Investigator

Conditions Herpes Zoster; Vascular Dementia; RO1; 1R01AG085406-01; Shingles; Dr. Stephen Tyring; Dementia risk HZ; VZV