A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Media… (NCT06903078) | Clinical Trial Compass
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A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.
United States375 participantsStarted 2025-02-13
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Analyze exosome content for known vascular damaging proteins/miRNAs from matched control and HZ individuals over a 12-month period.
Timeframe: From enrollment throughout the 5-year proposal period, occurring in a cyclical and overlapping manner.