First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in the Brains of Healthy Controls and Patients With Dementia.
David Wilson
Summary
This is a first in human study that will assess the safety and diagnostic performance of \[18F\]RP-115 (fluorine-18 labeled RP115), a positron emission tomography (PET) agent. This agent has the potential to identify the early changes that occur in the brains of patients with Alzheimer's disease (AD) and frontotemporal dementia (FTD).
Description
AD and FTD are the two leading causes of dementia with tremendous impact on patients and their families. Early diagnosis of both AD and FTD is essential to increase patients' quality of life, identify and treat reversible causes, and enhance the development and effectiveness of treatments. However, no single diagnostic agent is currently available for either AD or FTD; instead, clinicians must rely on the patient's history and cognitive testing which often leads to delayed or incorrect diagnosis. Importantly AD and FTD have distinct regional patterns of neuronal loss and dysfunction in the bra…
Eligibility
- Age range
- 40–75 years
- Sex
- All
- Healthy volunteers
- Yes
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 s…
Interventions
- Drug[18F]RP-115 PET/MRI or PET/CT and MRI
An I.V. bolus injection of up to 10 millicurie (mCi) \[18F\]RP-115 will be administered, followed by a PET/MRI scan or by a combination of PET/CT and MRI
Location
- China Basin, UCSFSan Francisco, California