Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Tra… (NCT05337774) | Clinical Trial Compass
TerminatedPhase 1
Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury
Stopped: study funding period ended March 2022
United States18 participantsStarted 2021-06-07
Plain-language summary
The main objective of this interdisciplinary study is to develop an understanding of the molecular imaging features of blast-related mild traumatic brain injury (mTBI) in military personnel, while helping to establish assessment tools that may be of use in diagnosis, determining prognosis, and in future therapeutic clinical trials. Additionally, the objective is to evaluate feasibility of \[18F\]PI-2620 in the assessment TBI.
Who can participate
Age range25 Years – 54 Years
SexMALE
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Inclusion criteria
✓. Male
✓. Right-handed
✓. Age 25-54
✓. Agree to participate in ALL study procedures
✓. English speaking
✓. Ambulatory
✓. Must be able to identify a study partner who is well acquainted with the participant for at least 2 years, to answer questions either in person or over the telephone about the participants' activities of daily living, and to corroborate behavioral and cognitive problems and history of brain injury
✓. History of combat deployment
Exclusion criteria
✕. Had a moderate or severe brain injury that required hospitalization
✕. Significant systemic illness or unstable medical conditions including: uncontrolled diabetes mellitus, uncorrected hypothyroidism or hyperthyroidism, or systemic cancer
What they're measuring
1
Tau deposition in the brain as measured with PI-2620 PET
Timeframe: 1 day
2
Amyloid deposition in the brain as measured with Florbetaben PET
✕. Diagnosis of schizophrenia, psychosis, or other psychological disorder (Note: blast-related mTBI group will not be excluded if they have a stable diagnosis of post-traumatic stress disorder, depression and anxiety resulting from their military experience; disorders existing prior to military service will serve as an exclusion)
✕. Current and active alcohol or substance abuse or dependence (DSM V criteria) within the past 6 months
✕. Clinically significant laboratory test abnormalities (such as hematology, chemistry, urinalysis, ECG) or significant impairment of liver or renal function
✕. Significant cerebrovascular disease (such as TIA, stroke) or cardiovascular disease (such as uncontrolled hypertension, atrial fibrillation)
✕. Impairment of visual or auditory acuity sufficient to interfere with completion of study procedures