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Compensation: Varies

Number of Visits: 1

100 Participants Needed

Neuroinflammation Imaging for Alzheimer's Disease

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Val Lowe

Must not be taking: NSAIDs, Corticosteroids

Disqualifiers: Pregnancy, Generalized inflammation, MRI safety, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

If you are actively taking daily anti-inflammatory medications, you may need to stop, as these are generally excluded from the trial. However, a small control group may be allowed to continue. Please check with the trial coordinators for specific guidance.

What data supports the effectiveness of the drug C-11 ER-176 for Alzheimer's disease?

The research highlights the importance of imaging neuroinflammation in Alzheimer's disease, which is a key feature of the condition. While C-11 ER-176 is not specifically mentioned, the studies emphasize the role of imaging techniques like PET in understanding and tracking neuroinflammation, which could indirectly support the use of similar imaging agents in Alzheimer's research.¹ ² ³ ⁴ ⁵

How does this treatment for Alzheimer's disease differ from other treatments?

This treatment is unique because it uses advanced imaging techniques like positron emission tomography (PET) to non-invasively detect and track neuroinflammation in the brain, which is a key factor in Alzheimer's disease. Unlike traditional treatments that focus on symptoms or protein deposits, this approach aims to understand and monitor the inflammatory processes, potentially aiding in early diagnosis and treatment monitoring.⁴ ⁶ ⁷ ⁸ ⁹

What is the purpose of this trial?

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.

Research Team

Val Lowe, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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.

Inclusion Criteria

You need to be in one of the four groups (CU A-, CU A+, MCI A+, AD A+).

I have been undergoing cognitive tests for at least 3 years.

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

See 2 more

Exclusion Criteria

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

I cannot stay still lying down for 20 minutes.

I take daily anti-inflammatory medication.

See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive a single administration of the C-11 ER176 radiotracer followed by PET/CT imaging to measure neuroinflammation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging, including assessment of adverse events

4 years

Treatment Details

Interventions

C-11 ER-176

Trial Overview 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.

Participant Groups

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.

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Who Is Running the Clinical Trial?

Val Lowe

Lead Sponsor

Trials

Recruited

100+

Findings from Research

Neuroinflammation is a key factor in the development of Alzheimer's disease, with increased glial cell activation observed in both animal models and human patients, highlighting its potential role in disease progression.

Current imaging techniques, such as positron emission tomography (PET) and magnetic resonance spectroscopy (MRS), are being explored to non-invasively detect and quantify neuroinflammation, which could improve early diagnosis and therapeutic monitoring in Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo molecular imaging of neuroinflammation in Alzheimer's disease.Chaney, A., Williams, SR., Boutin, H.[2020]

Molecular imaging with specific probes like (11)C-PIB and (18)F-AV-45 is crucial for the early diagnosis of Alzheimer's disease (AD) and helps evaluate the effectiveness of anti-AD therapies, which is essential given the rising number of cases.

These imaging probes not only aid in identifying the underlying biology of AD but also assist in selecting patients for clinical trials and monitoring treatment responses, potentially improving patient outcomes and guiding therapeutic decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances of molecular imaging probes for the diagnosis of Alzheimer's disease.Zhou, M., Wang, X., Liu, Z., et al.[2022]

The use of [11C](R)-PK11195 PET imaging allows for the detection of neuroinflammatory changes in the brain, which can be crucial for understanding various brain diseases and their progression.

This method focuses on measuring the activity of microglia, the brain's immune cells, rather than just assessing neuronal damage, highlighting its potential as a marker for disease activity in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In vivo imaging of neuroinflammation.Cagnin, A., Gerhard, A., Banati, RB.[2019]