A Study That Collects Participant Data and Biospecimens to Analyze Pathogenic Exosomes That Mediate Increased Vascular Dementia Risk in Individuals With Herpes Zoster.

Part of paid clinical trials in Houston, Texas.

Sponsor
Center for Clinical Studies, Texas
Study ID
NCT06903078
Status
Recruiting

Conditions

  • Herpes Zoster (HZ)
  • Vascular Dementia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Feb 13, 2025
Status verified
Dec 2025
Primary completion
Jul 31, 2029
Completion
Aug 31, 2030

Study Design

Enrollment
375 participants (estimated)

Arms

  • Arm: HZ (Herpes Zoster) Group
    Participants with untreated acute herpes zoster outbreak.
  • Arm: Control Group
    Participants without acute herpes zoster outbreak.

Primary Outcome Measure

Analyze exosome content for known vascular damaging proteins/miRNAs from matched control and HZ individuals over a 12-month period. [ Time Frame: From enrollment throughout the 5-year proposal period, occurring in a cyclical and overlapping manner. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Center for Clinical Studies, LTD. LLPHoustonTexas77004
Stephen K. Tyring, MD
713-528-8818
Mario Guerrero
Stephen K. Tyring, MD (PRINCIPAL_INVESTIGATOR)
Center for Clinical Studies, LTD. LLPWebsterTexas77598
Stephen K. Tyring, MD
281-333-2288
Deb Yetman, RN
281-333-2288
Stephen K Tyring, MD (PRINCIPAL_INVESTIGATOR)
Patricia C Lee, MD (SUB_INVESTIGATOR)

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