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no history of TBI (control group 2) for Concussion

Phase 1
Waitlist Available
Research Sponsored by Life Molecular Imaging SA
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 weeks
Awards & highlights

Study Summary

This trialseeks to develop imaging tools to diagnose, prognose and treat traumatic brain injury in military personnel. [18F]PI-2620 a potential imaging biomarker.

Eligible Conditions
  • Concussion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amyloid deposition in the brain as measured with Florbetaben PET
Brain
Secondary outcome measures
Correlation of brain MR imaging with PI-2620 brain PET imaging
Neurocognitive deficits present in military personnel with blast-related mTBI as measured with NICoE

Trial Design

3Treatment groups
Experimental Treatment
Group I: no history of TBI (control group 2)Experimental Treatment1 Intervention
Assessments will include:(i) neuropsychological and neurobehavioral testing, (ii) MRI, with a special emphasis on (iii) PET, using emerging tracers for tauopathy ([18F]PI-2620), and amyloid ([18F]florbetaben).
Group II: mTBI not blast-related (control group 1)Experimental Treatment1 Intervention
Assessments will include:(i) neuropsychological and neurobehavioral testing, (ii) MRI, with a special emphasis on (iii) PET, using emerging tracers for tauopathy ([18F]PI-2620), and amyloid ([18F]florbetaben).
Group III: Blast-related mTBI groupExperimental Treatment1 Intervention
Assessments will include:(i) neuropsychological and neurobehavioral testing, (ii) MRI, with a special emphasis on (iii) PET, using emerging tracers for tauopathy ([18F]PI-2620), and amyloid ([18F]florbetaben).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[18F]PI-2620
2018
Completed Phase 2
~150

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Walter Reed National Military Medical CenterFED
137 Previous Clinical Trials
34,479 Total Patients Enrolled
Life Molecular Imaging SALead Sponsor
18 Previous Clinical Trials
1,176 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury
2021. "Imaging [18F]PI-2620 and [18F]Florbetaben in Military Service Members With Blast Related Mild Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05337774.
All > Tbi > Traumatic Brain Injury
~5 spots leftby Apr 2025
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