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New treatment option for Alzheimer Disease
Official title First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Dementia
ClinicalTrials.gov ID: NCT05374278
What this study is testing
What is [18F]RP-115 PET/MRI or PET/CT and MRI?
[18F]RP-115 PET/MRI or PET/CT and MRI is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for alzheimer disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75. Healthy volunteers may be eligible.
You may be able to join if
- Age 40-75
- Age-suitable BMI
- Ability to provide written informed consent and willingly comply with protocol requirements or has a legal authorized representative/guardian who...
- No apparent physical disorder.
- Radial, ulnar, or brachial artery suitable for catheterization.
You likely can't join if
- Unable to provide written informed consent and unwilling to comply with protocol requirements, or does not have a legal authorized...
- Inadequate arterial access.
- Receipt of radioisotope \ two weeks) PET scans.
- The performed [18F]RP-115 scan(s) must not represent \> 3 PET studies total within one year.
- Contra-indication to magnetic resonance, including permanent pacemaker, implantable metallic device, etc.; or severe claustrophobia.
- Participants who are pregnant (female patients of childbearing age will be tested prior to injection of tracer- positive test excludes from the study)
See the full eligibility criteria
- Age 40-75
- Age-suitable BMI
- Ability to provide written informed consent and willingly comply with protocol requirements or has a legal authorized representative/guardian who provides surrogate informed consent.
- No apparent physical disorder.
- Radial, ulnar, or brachial artery suitable for catheterization.
- Non-smoker, and not taking OTC nicotine cessation - to limit peripheral metabolism events.
- Devoid of CNS prescription drugs for three weeks - to limit peripheral metabolism events. For Cohort 2B and 2C:
- 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...
- Recent (within 6 mo.) MME clinical scores.
- 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.
- Inadequate arterial access.
- Receipt of radioisotope \ two weeks) PET scans.
- The performed [18F]RP-115 scan(s) must not represent \> 3 PET studies total within one year.
- Contra-indication to magnetic resonance, including permanent pacemaker, implantable metallic device, etc.; or severe claustrophobia.
- Participants who are pregnant (female patients of childbearing age will be tested prior to injection of tracer- positive test excludes from the study)
- Participants who are breast-feeding.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.