Recruiting

Observational Study

Sponsor:

Roskamp Institute Inc.

Code:

NCT06883227

Conditions

Red Tide

Neurologic Disorder

Florida

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

The goals of this project are to study the biological effects of environmental toxins (ET), in particular aquatic toxins such as brevetoxins (PbTx) and microcystin or their metabolites. This study is designed to examine the effects of the body from harmful algae blooms (HAB) as well as possibility of an association between exposure to the marine toxin, brevetoxin (PbTx), which is released from K. brevis during the red tide bloom, and the prevalence of neurological illnesses.

Conditions

Red Tide

Neurologic Disorder

Florida

Study ID

NCT06883227

Start date

Oct 14, 2024

Status verified date

Mar, 2025

Completion date

Oct 14, 2030

Anticipated

Primary completion date

Oct 14, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Subject should be able to provide written informed consent.
2. Adult aged 18 or older.
3. Resident (temporary or permanent) of one of the following five southwest Florida counties (Lee, Collier, Charlotte, Sarasota, or Manatee).
4. Any race or ethnicity.
5. Willing to return for at least a total of four study visits and participate in all required procedures for the duration of the study.

Exclusion Criteria:

1. Inability to speak or write in English.
2. Any medical condition for which the study investigator believes enrollment is medically inappropriate.
3. Unwilling/unable to provide biological samples or poor venous access.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Main Study

All subjects will be asked to complete four in-person visits where the goal is for two visits to take place during the K. brevis bloom period and the other two visits will be when there is no K. brevis bloom ("not present" range according to the FWC K. brevis cell counts).

Sub-Study

Sponsor will enroll 45 randomly selected participants from the main cohort of participants who met the inclusion/exclusion criteria and agreed to take part in the PK sub-study. The only additional exclusion criteria will be pregnancy at the time of PK study. Participants will be asked to take part in the sub-study after their first visit where there was no bloom present. Participants in the relevant locations (areas in which there is red tide bloom present) will be contacted to initiate the PK studies, and data from their prior visit (when there was no red tide bloom present) will represent their baseline data (D0).

Primary outcome measure

  • Examination of marine or similar environmental toxins short-term and long-term adverse effects on central nervous system (CNS) health, immune system, respiratory health and other biological effects induced by aquatic environmental or related toxins. [ Time Frame: 4 years ]

Central Contacts and Locations

Central contacts

Dakota Helgager Clinical Research Site Coordinator, Bachelor's

9412568010redtide@roskampclinic.org

Ayse Cemek Clinical Research Coordinator, Bachelors

9412568010redtide@roskampclinic.org

Locations

The Roskamp Institute

Recruiting

Sarasota, Florida, United States, 34232

Contacts

Dakota M Helgager, B.S

9412568010redtide@roskampclinic.org

Ayse Cemek, B.S

9412568019acemek@roskampclinic.org

Principal Investigator:

Laila Abdullah, Ph.D

More Information

Sponsor

Roskamp Institute Inc.

Last update posted

Mar 24, 2025

Last verified

Mar, 2025

Keywords

  • Brain fog
  • Red Tide
  • respiratory
  • coughing
  • neurotoxin
  • beach
  • florida

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roskamp Institute Inc. on 2025-03-24.