102 Participants Needed

EAAT2 PET Tracer for Dementia

HV
DW
Overseen ByDavid Wilson, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent that can be seen with a PET scan to detect early brain changes in patients with Alzheimer's disease and frontotemporal dementia. The agent targets a specific brain protein that is less active in these diseases. By identifying these changes early, doctors hope to improve diagnosis and treatment.

Will I have to stop taking my current medications?

Yes, you must stop taking any central nervous system (CNS) prescription drugs for three weeks before participating in the trial.

How does the EAAT2 PET tracer treatment for dementia differ from other treatments?

The EAAT2 PET tracer for dementia is unique because it focuses on imaging a specific protein involved in brain function, which may help in diagnosing and understanding dementia. Unlike traditional treatments that aim to alleviate symptoms, this tracer is used for diagnostic imaging to observe brain changes, potentially leading to more targeted therapies in the future.12345

What data supports the effectiveness of the drug [18F]RP-115 for dementia?

The research highlights the use of PET imaging with various tracers, like [18F] AV-45, in diagnosing Alzheimer's disease and other dementias. These tracers help visualize brain changes, such as amyloid protein buildup, which are important for early diagnosis and understanding dementia. While [18F]RP-115 is not directly mentioned, similar tracers have shown effectiveness in studying dementia-related brain changes.16789

Who Is on the Research Team?

DW

David Wilson, MD, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults aged 40-75 with suitable arteries for catheterization, non-smokers, not on CNS drugs for three weeks, and those who can consent or have a guardian to do so. Pregnant or breastfeeding individuals and those with certain medical devices or conditions that could affect the study's outcome are excluded.

Inclusion Criteria

I do not have any visible physical disorders.
Ability to provide written informed consent and willing to comply with protocol requirements, or has a legal authorized representative/guardian who provides surrogate informed consent
My arm's main arteries are suitable for a catheter procedure.
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Exclusion Criteria

You cannot have a magnetic resonance imaging (MRI) scan because you have a pacemaker, implantable metallic device, or severe fear of enclosed spaces.
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
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dosimetry and Safety Assessment

Whole-body PET/MRI scan conducted immediately after [18F]RP-115 injection to establish safety and dosimetry in healthy volunteers

3.5 hours per session, over a year
Multiple sessions (in-person)

Diagnostic Performance Evaluation

Utilize [18F]RP-115 to assess regional cerebral binding differences in healthy volunteers compared to AD and FTD patients

3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including a follow-up 24-48 hours after [18F]RP-115 administration

1-2 days post-administration

What Are the Treatments Tested in This Trial?

Interventions

  • [18F]RP-115
Trial Overview [18F]RP-115 PET/MRI or PET/CT along with MRI is being tested to see if it can detect early brain changes in Alzheimer's and frontotemporal dementia patients. This first-in-human study evaluates the safety and diagnostic capabilities of this new imaging agent.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Cohort 2C - [18F]RP-115 in patients with FTDExperimental Treatment1 Intervention
Comparison of \[18F\]RP-115 PET binding between AD patients and age-matched cognitively normal controls and between AD and FTD
Group II: Cohort 2B - [18F]RP-115 in patients with ADExperimental Treatment1 Intervention
Comparison of \[18F\]RP-115 PET binding between AD patients and age-matched cognitively normal controls and between AD and FTD
Group III: Cohort 2A - [18F]RP-115 in age-matched controlsExperimental Treatment1 Intervention
Comparison of \[18F\]RP-115 PET binding between AD patients and age-matched cognitively normal controls and between AD and FTD
Group IV: Cohort 1 - dosimetry of [18F]RP-115 in healthy volunteersExperimental Treatment1 Intervention
Establish \[18F\]RP-115 safety in the clinic with male and female PET imaging.

Find a Clinic Near You

Who Is Running the Clinical Trial?

David Wilson

Lead Sponsor

Trials
1
Recruited
100+

Rio pharmaceuticals Inc.

Collaborator

Trials
1
Recruited
100+

Published Research Related to This Trial

Positron emission tomography (PET) using FDG is crucial for measuring regional cerebral glucose metabolism in Alzheimer's disease, revealing specific areas of reduced metabolism that can help in early diagnosis and understanding of the disease.
PET imaging can also assess neuroinflammation and amyloid deposition using different tracers, making it a versatile tool in dementia research for evaluating brain function and the effectiveness of new treatments.
Positron emission tomography imaging in dementia.Herholz, K., Carter, SF., Jones, M.[2022]
Recent advancements in molecular biology and genetics have led to the development of specific biomarkers and imaging techniques, such as amyloid and tau PET scans, which allow for the early detection and differentiation of Alzheimer's disease and other dementias.
These imaging methods, including FDG PET and dopamine transporter SPECT, provide valuable insights into brain metabolism and function, enhancing diagnostic accuracy and potentially guiding treatment strategies.
What is New in Nuclear Medicine Imaging for Dementia.Topçuoğlu, ES., Akdemir, ÜÖ., Atay, LÖ.[2023]
Positron emission tomography (PET) is a valuable tool for detecting early functional changes in the brain associated with Alzheimer's disease (AD), even before structural changes are visible on traditional imaging like MRI.
The review focuses on various (18)F- and (11)C-labelled PET tracers that can help in diagnosing AD early, understanding its pathophysiology, and monitoring treatment effects, highlighting their potential in improving patient outcomes.
Radiopharmaceuticals for positron emission tomography investigations of Alzheimer's disease.Någren, K., Halldin, C., Rinne, JO.[2021]

Citations

Positron emission tomography imaging in dementia. [2022]
What is New in Nuclear Medicine Imaging for Dementia. [2023]
Radiopharmaceuticals for positron emission tomography investigations of Alzheimer's disease. [2021]
4.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Simple Synthesis of [18F] AV-45 and its Clinical Application in the Diagnosis of Alzheimer's Disease. [2023]
PET/CT in diagnosis of dementia. [2022]
Tau PET imaging with 18F-PI-2620 in Patients with Alzheimer Disease and Healthy Controls: A First-in-Humans Study. [2022]
Quantification of Tau Load Using [18F]AV1451 PET. [2019]
Development and evaluation of [18F]Flotaza for Aβ plaque imaging in postmortem human Alzheimer's disease brain. [2023]
An updated radiosynthesis of [18F]AV1451 for tau PET imaging. [2022]
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