What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease, such as cholinesterase inhibitors (e.g., donepezil, rivastigmine, and galantamine), often have side effects including nausea, vomiting, diarrhea, muscle cramps, and fatigue. PET imaging agents like [18F]flutemetamol, used for detecting amyloid plaques, are generally well tolerated but can occasionally cause injection site reactions and mild headaches. Investigational agents targeting amyloid plaques or other brain changes may also have side effects, but these are typically specific to the agent and require further study to fully understand their safety profiles.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, primarily focusing on symptom management and slowing disease progression. Notable approvals include cholinesterase inhibitors like donepezil, rivastigmine, and galantamine, and the NMDA receptor antagonist memantine. Recently, the FDA approved aducanumab, a monoclonal antibody targeting amyloid-beta plaques, which is a hallmark of Alzheimer's pathology. For diagnostic purposes, the FDA has approved PET imaging agents such as florbetapir (Amyvid), flutemetamol (Vizamyl), and florbetaben (Neuraceq), which help visualize amyloid plaques in the brain. These imaging agents are similar to [18F]RP-115 in their use of PET technology to detect early brain changes associated with Alzheimer's Disease.

What other types of research exist?

Promising alternatives to [18F]RP-115 for PET imaging in Alzheimer's Disease include [18F]florbetapir, [18F]flutemetamol, and [18F]florbetaben. These agents are used to detect amyloid plaques, a hallmark of Alzheimer's Disease. Additionally, tau PET tracers like [18F]flortaucipir are emerging as valuable tools for detecting tau pathology in the brain, which is another key feature of Alzheimer's Disease.

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EAAT2 PET Tracer for Dementia

Phase 1 & 2

Recruiting

Led By David Wilson, MD, PhD

Research Sponsored by David Wilson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Radial, ulnar or brachial artery suitable for catheterization

Age 40-75 years old

Must not have

Participants who are pregnant (female patients of childbearing age will be tested prior to injection of tracer- positive test excludes from the study)

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up a year

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

[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.

What are the potential side effects?

As this is a first-in-human study primarily focused on assessing safety, specific side effects of [18F]RP-115 are not yet known but will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My arm's main arteries are suitable for a catheter procedure.

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I am between 40 and 75 years old.

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I do not smoke or use nicotine replacement therapies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant.

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I cannot or will not follow the study rules, or no one can consent for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~three years

This trial's timeline: 3 weeks for screening, Varies for treatment, and three years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Biodistribution of [18F]RP-115

Dosimetry of [18F]RP-115

Safety of Administered dose

Secondary study objectives

[18F]RP-115 diagnostic performance

Awards & Highlights

No Placebo-Only Group

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

Trial Design

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.

0 / 5Eligibility criteria met

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

The most common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine). Cholinesterase inhibitors work by preventing the breakdown of acetylcholine, a neurotransmitter important for learning and memory, thereby enhancing cholinergic function. Memantine regulates glutamate activity to prevent excitotoxicity, which can damage neurons. These treatments aim to alleviate symptoms and improve cognitive function, although they do not cure the disease. The relevance of these mechanisms lies in their ability to temporarily stabilize or slow the progression of symptoms, providing patients with improved quality of life. Imaging agents like [18F]RP-115 are crucial for early detection and monitoring of disease progression, potentially allowing for timely intervention and better management of AD.

Imaging β-amyloid using [(18)F]flutemetamol positron emission tomography: from dosimetry to clinical diagnosis.