What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (such as donepezil, rivastigmine, and galantamine) and memantine. Known side effects of cholinesterase inhibitors can include gastrointestinal issues (nausea, vomiting, diarrhea), muscle cramps, fatigue, and insomnia. Memantine may cause dizziness, headache, confusion, and constipation. For treatments involving radiotracers like C-11 ER176 used in PET/CT imaging, potential side effects could include exposure to radiation, which carries a risk of radiation-induced damage, though specific side effects of C-11 ER176 are not detailed in the provided context.

What prior FDA approvals exist?

FDA-approved treatments for Alzheimer's Disease primarily include cholinesterase inhibitors (donepezil, rivastigmine, and galantamine) and the NMDA receptor antagonist memantine. These medications aim to manage symptoms and improve cognitive function. While the context does not provide specific information on FDA-approved radiotracers for PET/CT imaging in Alzheimer's, ongoing research, such as the trial involving C-11 ER176, focuses on using radiotracers to measure brain inflammation and its relation to Alzheimer's Disease.

What other types of research exist?

Promising alternatives to C-11 ER176 for PET/CT imaging in Alzheimer's Disease include: 1) Florbetapir F-18, which binds to amyloid plaques and is FDA-approved for detecting amyloid pathology. 2) Flortaucipir F-18, which targets tau tangles and is also FDA-approved. 3) Fluoroestradiol F-18, which, although primarily used for breast cancer, has potential applications in neuroinflammation imaging. These agents offer specific targeting of Alzheimer's-related brain changes and are likely to be relevant in 2024.

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Neuroinflammation Imaging for Alzheimer's Disease

Phase 2

Waitlist Available

Led By Val Lowe, MD

Research Sponsored by Val Lowe

Eligibility Criteria Checklist

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

Must have

Males or females 60 years of age or older

Capacity to sign consent or have a legally authorized representative to sign the consent

Must not have

Participants unable to lie down without moving for 20 minutes

Actively taking daily anti-inflammatory medications (NSAIDs, corticosteroids, etc.) except for a small control group

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 year

Awards & highlights

No Placebo-Only Group

Summary

This trial uses a special brain scan with a new substance to highlight brain inflammation. It targets people with Alzheimer's Disease and those with brain issues. The scan helps doctors see inflammation in the brain.

Who is the study for?

This trial is for men and women over 60 who are part of a cognitive study group, have had recent brain scans, and can consent to the study. Pregnant or breastfeeding women, those unable to lie still for scans, on daily anti-inflammatory meds, with generalized inflammation or metal in their body that affects MRI safety cannot join.

What is being tested?

Researchers are testing a new radioactive tracer called C-11 ER176 using PET/CT imaging to measure brain inflammation related to Alzheimer's Disease. They want to see if this method can help understand the disease better.

What are the potential side effects?

Potential side effects may include reactions from the radiotracer C-11 ER176 used during PET/CT imaging but specific side effects are being studied as part of this research.

Eligibility Criteria

Inclusion Criteria

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

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I am 60 years old or older.

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I can sign the consent myself or have someone legally allowed to do it for me.

Exclusion Criteria

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

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I cannot stay still lying down for 20 minutes.

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I take daily anti-inflammatory medication.

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I am not pregnant and can stop breastfeeding for 24 hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Determine if neuroinflammation, as measured by C-11 ER176 SUVr and inflammatory blood test measurements, is correlated with an increase in AB plaque, as measured by C-11 PiB SUVr.

Determine if neuroinflammation, as measured by C-11 ER176 SUVr, is correlated with a history of increased cognitive decline in the 5 years preceding PET imaging, as measured by z scores from neuropsychiatric test results (memory, etc.).

Determine if neuroinflammation, as measured by PET imaging, is associated with plasma biomarkers of inflammation.

Secondary study objectives

Incidence of adverse events attributable to ER176.

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: C-11 ER176 PET/CTExperimental Treatment2 Interventions

C-11 ER176 is an investigational radiopharmaceutical that will be produced under cGMP in the Mayo Clinic Cyclotron Facility. The imaging agent (C-11 ER176) will be administered on an outpatient basis. It will be administered at a single time IV prior to the PET imaging.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Blood Test

2021

N/A

~360

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 include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and NMDA receptor antagonists (memantine). Cholinesterase inhibitors work by increasing the levels of acetylcholine in the brain, which helps improve communication between nerve cells and can alleviate some symptoms of AD. Memantine works by regulating the activity of glutamate, a neurotransmitter involved in learning and memory, to prevent excessive neuronal damage. These treatments are symptomatic and do not alter the disease's progression. In the context of radiotracers like C-11 ER176, which bind to specific brain targets to measure inflammation, understanding these mechanisms is crucial as it helps in assessing the effectiveness of treatments and the progression of neuroinflammation in AD patients.