First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Dementia

Launched by DAVID WILSON · May 9, 2022

Keywords

ClinConnect Summary

This clinical trial is testing a new imaging agent called \[18F\]RP-115, which may help doctors see early changes in the brains of people with Alzheimer’s disease and frontotemporal dementia. The goal is to find out if this agent is safe to use and how well it can help diagnose these conditions. The study is currently recruiting participants aged 40 to 75 who are generally healthy and can provide consent. Having a study partner, like a family member or close friend, who can share information about your daily activities and accompany you during the study is also important.

Participants will undergo a special scan called a PET scan using the \[18F\]RP-115 agent. Before joining, individuals need to meet specific requirements, such as not currently using certain medications or having certain health conditions. Throughout the trial, everyone will be closely monitored to ensure safety and gather useful information about the agent's effectiveness. If you or someone you know is interested in participating, it’s a great opportunity to contribute to research that could improve the understanding and diagnosis of dementia-related diseases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 40-75
• • 2. Age-suitable BMI
• • 3. Ability to provide written informed consent and willingly comply with protocol requirements or has a legal authorized representative/guardian who provides surrogate informed consent.
• • 4. No apparent physical disorder.
• • 5. Radial, ulnar, or brachial artery suitable for catheterization.
• • 6. Non-smoker, and not taking OTC nicotine cessation - to limit peripheral metabolism events.
• • 7. Devoid of CNS prescription drugs for three weeks - to limit peripheral metabolism events.
• For Cohort 2B and 2C:
• • 8. Must have a study partner (informant) who spends a minimum average of 5 hours per week with the participant (e.g. family member, significant other, friend, caregiver), is generally aware of the participant's daily activities, can provide information about the participant's cognitive and functional performance, and will accompany the participant in all study procedure.
• • 9. Recent (within 6 mo.) MME clinical scores.
• Exclusion Criteria:
• • 1. Unable to provide written informed consent and unwilling to comply with protocol requirements, or does not have a legal authorized representative/guardian who can provide surrogate informed consent.
• • 2. Inadequate arterial access.
• • 3. Receipt of radioisotope \< 5 half-lives within \[18F\]RP-115 imaging- as to not confound any scans with radiation background for previous scanning, and unsuitable organ dosimetry thresholds from previous (\> two weeks) PET scans.
• • 4. The performed \[18F\]RP-115 scan(s) must not represent \> 3 PET studies total within one year.
• • 5. Contra-indication to magnetic resonance, including permanent pacemaker, implantable metallic device, etc.; or severe claustrophobia.
• • 6. Participants who are pregnant (female patients of childbearing age will be tested prior to injection of tracer- positive test excludes from the study)
• • 7. Participants who are breast-feeding.
• • 8. Have a medical condition or other circumstances that in the opinion of the project physicians would significantly decrease chances of obtaining reliable data, achieving the study objective or completing the study.