Shingles and the Risk of Vascular Dementia: Studying Exosomes
Studies whether shingles raises vascular dementia risk in adults.
Key facts
- Who runs it
- Center for Clinical Studies, Texas
- Where
- Houston and Webster, United StatesSee the 2 sites
- Trial code
- Registry title
- A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.
- Status
- Recruiting
- People taking part
- 375 people, planned
- Started
- 13 Feb 2025
- Expected to end
- Aug 2030
- Type of study
- Observational, 2 groups
- Record updated
- 11 December 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who come to a skin clinic, either with new, untreated shingles (herpes zoster) or without shingles as a comparison group. It studies whether shingles raises the risk of blood vessel problems and vascular dementia.
- Age
- 18 years and older
- Sex
- All sexes
- Disease stage
- Shingles group: acute shingles at the blister (vesicle) stage. Control group: no shingles.
- Earlier treatment
- Shingles group: the shingles must not have been treated with antiviral medicines. People who had a shingles vaccine (e.g., Zostavax®/Shingrix®) within the last 8 years, or any vaccine within the last 3 months, cannot join.
Main reasons for not taking part
- Pregnant or breast-feeding
- Taking immune-suppressing treatment or blood thinners (anticoagulants), or have a blood clotting disorder
- Shingles diagnosed within the last 8 years
- History of HIV, end-stage kidney or liver disease
- Stroke or heart attack in the past 12 months, or COVID-19 or a serious infection needing hospital care in the last 3 months
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- 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
Who cannot take part
- Receiving systemic or topical antivirals for varicella zoster virus (VZV)
- 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
- Prior history of cardiovascular accident or myocardial infarction within the last 12 months
- Prior cerebrovascular accident in the past 12 months
- Sensitivity or allergy to systemic or topical antiviral medications for HZ
- History of diagnosed HZ within the last 8 years
- 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
- 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
Where in United States
- Center for Clinical Studies, LTD. LLPHouston, United StatesContact: Stephen K. Tyring, MDTaking people
- Center for Clinical Studies, LTD. LLPWebster, United StatesContact: Stephen K. Tyring, MDTaking people
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- HZ (Herpes Zoster) Group
Participants with untreated acute herpes zoster outbreak.
- Control Group
Participants without acute herpes zoster outbreak.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pathogenic Exosomes During Herpes Zoster Mediate Increased Vascular Dementia Risk.
- Plain-language title
- Shingles and the Risk of Vascular Dementia: Studying ExosomesGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 11 December 2025