What side effects are associated with this type of intervention?

Common treatments for concussion include rest, cognitive and physical therapy, and medications for symptom management. Rest and therapy generally have minimal side effects, though overexertion can delay recovery. Medications such as pain relievers (e.g., acetaminophen) are usually well-tolerated but can cause liver damage if overused. Nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen may cause gastrointestinal issues or increase bleeding risk. Neuroimaging techniques like PET scans, including those using Florbetaben F 18, are generally safe but involve exposure to low levels of radiation, which carries a minimal risk of cancer over a lifetime.

What prior FDA approvals exist?

There are no FDA-approved treatments specifically for concussion that are similar to the Neuraceq™ (Florbetaben F 18 Injection) PET trial, which aims to detect amyloid plaques in the brain. The context provided does not mention any FDA approvals for drugs or treatments targeting concussion in a manner similar to amyloid plaque detection. Current concussion management primarily involves rest, symptom management, and gradual return to activities.

What other types of research exist?

Promising alternatives to Neuraceq™ PET for detecting amyloid plaques in concussion patients include: 1) Tau PET imaging, which targets tau protein aggregates associated with neurodegeneration. 2) Advanced MRI techniques, such as diffusion tensor imaging (DTI) and functional MRI (fMRI), which can provide detailed insights into brain structure and function changes post-concussion. 3) Blood-based biomarkers, which are emerging as non-invasive methods to detect brain injury and amyloid pathology.

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Diagnostic Test

Neuraceq™ PET Imaging for Concussion

N/A

Waitlist Available

Led By Marc A Seltzer, MD

Research Sponsored by Dartmouth-Hitchcock Medical Center

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 90 minutes after injection

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special brain scan to detect changes in the brains of former college athletes who have had concussions. The scan helps visualize brain activity and identify any long-term damage. The study focuses on athletes with ongoing cognitive issues to understand the lasting effects of concussions.

Who is the study for?

This trial is for young athletes aged 18-40 who have had at least one concussion, as defined by the American Congress of Rehabilitative Medicine, and are at least one year post their first concussion. They must show signs of persistent cognitive issues. Those who can't join include pregnant individuals, people with other neurological disorders or significant illnesses, and those with current severe psychiatric diagnoses.

What is being tested?

The study is testing if Neuraceq™ PET scans can reveal brain changes in athletes who've had concussions. Participants will receive an IV dose of Neuraceq™ to help detect these potential changes from injuries that occurred at least five years prior.

What are the potential side effects?

While not explicitly stated here, common side effects associated with PET imaging agents like Neuraceq™ may include injection site reactions such as pain or swelling, nausea, headache, or a feeling of discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 minutes after injection

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 minutes after injection

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 minutes after injection for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cognitive Assessment_1

Cognitive Assessment_2

Neuraceq™ PET Imaging

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Athletes with persistent cognitive deficits due to mild to moderate traumatic brain injury (mTBI)Active Control1 Intervention

Young athletes who have sustained one or more concussions with persistent cognitive complaints at least one year post-injury in spite of medical and cognitive treatment intervention.

Group II: Athletes with mild to moderate traumatic brain injury (mTBI) and good outcomeActive Control1 Intervention

Young athletes who have sustained one or more concussions without persistent cognitive complaints at least one year post-injury

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for concussion primarily focus on rest, both cognitive and physical, to allow the brain to heal. Medications may be used to manage symptoms such as headaches, nausea, and sleep disturbances. Cognitive rehabilitation and physical therapy can also be employed to address specific deficits. The use of Neuraceq™ (Florbetaben F 18 Injection) PET imaging in concussion patients is significant as it helps detect amyloid plaques, which may indicate long-term brain changes and potential risks for neurodegenerative diseases. This imaging can guide more targeted and effective treatment plans, emphasizing the importance of early and accurate diagnosis in managing concussion outcomes.

Alzheimer's Disease Cerebrospinal Fluid and Neuroimaging Biomarkers: Diagnostic Accuracy and Relationship to Drug Efficacy.[(18)F]Florbetaben: a review in β-amyloid PET imaging in cognitive impairment.Beta-amyloid imaging with florbetaben.