NCT05736146 Validating Gulf War Illness Blood Biomarkers
| NCT ID | NCT05736146 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Roskamp Institute Inc. |
| Condition | Gulf War Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-06-30 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2022-06-30 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators goals are to identify blood lipids/metabolites that correlate with cognitive decline in the presence of the APOE ε4 allele among veterans with GWI. To determine the effect of dietary, medical and biological factors that influence lipid and metabolites in blood from GW veterans. To identify blood lipid/metabolite profiles that correlate with bioenergetics deficits and glial activation in the brains of GWI. To validate blood biomarker signatures of GWI using APOE genotyping and blood lipids/metabolites that correlate with the CNS dysfunction in GWI.
Eligibility Criteria
Inclusion Criteria: 1. Age 35 years or older. 2. For GWI cases, served in the 1990-1991 Gulf War as active duty, national guard, or reserves and meet criteria for the CDC Chronic Multisymptom Illness (CMI) GWI definition or Kansas GWI definition. 3. For controls, must be a veteran in the same age range as those veterans with GWI as defined above. 4. Ability to understand written and spoken English or availability of a legal representative who can understand written or spoken English. Participants and caregiver/informants must be able to read, write and speak the language in which psychometric tests are provided with visual and auditory acuity (corrected) sufficient to allow for accurate testing. Exclusion Criteria: 1. Diagnosed or being treated by a physician for any of the following (Steele et al, 2000) and deemed clinically significant per the discretion of the PI: 1. Cancer (except for non-melanoma skin cancers) 2. Chronic infectious disease 3. Problems resulting from postwar injuries. 4. Liver disease 5. Lupus 6. Multiple sclerosis 7. Stroke 8. Serious psychiatric condition (those associated with psychosis and/or for which the respondent had been hospitalized since 1991). 9. Dementia or any type of Parkinson's disease (PD). 2. Hospitalized in the last 5 years for alcohol or drug dependence, depression, or post-traumatic stress disorder (PTSD). 3. Female subject is either pregnant or nursing.
Contact & Investigator
Laila Abdullah, Ph.D.
PRINCIPAL INVESTIGATOR
The Roskamp Institute
Frequently Asked Questions
Who can join the NCT05736146 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, studying Gulf War Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05736146 currently recruiting?
Yes, NCT05736146 is actively recruiting participants. Contact the research team at dhelgager@roskampclinic.org for enrollment information.
Where is the NCT05736146 trial being conducted?
This trial is being conducted at Palo Alto, United States, Sarasota, United States, Boston, United States.
Who is sponsoring the NCT05736146 clinical trial?
NCT05736146 is sponsored by Roskamp Institute Inc.. The principal investigator is Laila Abdullah, Ph.D. at The Roskamp Institute. The trial plans to enroll 100 participants.