20 Participants Needed

Neuroinflammation Imaging for Alzheimer's Disease

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Overseen ByIIya Nasrallah, MD
Age: 18+
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Pennsylvania
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to understand any specific requirements.

What data supports the idea that Neuroinflammation Imaging for Alzheimer's Disease is an effective treatment?

The available research does not provide direct evidence that Neuroinflammation Imaging for Alzheimer's Disease is an effective treatment. Instead, the studies focus on using imaging techniques to detect inflammation in the brain, which can help in diagnosing and understanding diseases like Alzheimer's. For example, one study used imaging to measure brain inflammation in Parkinson's disease, showing increased inflammation in patients compared to healthy individuals. However, this does not demonstrate that the imaging itself treats Alzheimer's disease. The research highlights the potential of these imaging methods for diagnosis and monitoring rather than treatment.12345

What data supports the effectiveness of the drug used in the Neuroinflammation Imaging for Alzheimer's Disease clinical trial?

Research shows that [18F]NOS PET imaging can effectively measure neuroinflammation in conditions like Parkinson's disease, suggesting it might also be useful for Alzheimer's. Additionally, [18F]PBR-111 has shown potential in imaging neuroinflammation in multiple sclerosis, indicating similar imaging agents could be beneficial for Alzheimer's disease.12345

What safety data exists for the neuroinflammation imaging treatment in Alzheimer's Disease?

The safety data for the neuroinflammation imaging treatment, which includes tracers like [11C]PBR28, [18F]NOS, and [18F]6-(2-fluoropropyl)-4-methylpyridin-2-amine, is primarily derived from preclinical studies. [11C]PBR28 has been evaluated in a rat model of herpes encephalitis, showing higher sensitivity in detecting neuroinflammation compared to (R)-(11)C-PK11195. [18F]NOS has been tested in a murine model of lung inflammation and in humans post-heart transplantation, with dosimetry studies indicating its potential for human use. [18F]6-(2-fluoropropyl)-4-methylpyridin-2-amine has been evaluated in a mouse model of iNOS activation, showing favorable properties as a PET tracer. These studies suggest the tracers are promising for imaging neuroinflammation, but comprehensive safety data in humans is limited.12367

Is the neuroinflammation imaging treatment safe for humans?

The safety of these imaging agents, such as [11C]PBR28 and [18F]NOS, has been evaluated in animal studies, showing their potential as safe PET tracers for detecting inflammation. However, specific human safety data is limited, and further studies are needed to confirm their safety in humans.12367

Is the treatment in the trial 'Neuroinflammation Imaging for Alzheimer's Disease' a promising treatment?

Yes, the treatment is promising because it uses advanced imaging techniques to detect and track neuroinflammation, which is important for understanding and managing Alzheimer's disease. This can help in early diagnosis and monitoring the effectiveness of therapies.12358

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

This treatment uses a PET imaging tracer to target inducible nitric oxide synthase (iNOS), which is involved in neuroinflammation, making it unique as it focuses on imaging inflammation rather than directly treating symptoms or plaques associated with Alzheimer's disease.12358

What is the purpose of this trial?

This research study is being done to learn more about inflammation in the brain using Positron Emission Tomography/Computed Tomography (PET/CT) imaging in people with Alzheimer's Disease/Mild Cognitive Impairment or healthy controls.If the subject agrees to be in this study, she/ he will have a PET/CT scan using the investigational radiotracer \[18F\]NOS. A subject with a specific genetic polymorphism may also agree to be in the sub-study in which she/he will have another PET/CT scan using the investigational tracer \[11C\]PBR28 for comparison with the FNOS \[18F\]NOS scan. For subjects who agree to this sub-study they may undergo the brain PET/CT scan with \[11C\]PBR28 either on the same day as the \[18F\]NOS PET/CT or on another day. The subject may have a screening visit before the PET/CT scan visit if the investigator needs to confirm the subject is able to be in the study.A blood sample will be taken before the scans. Additional blood samples will be taken during the PET scans. Subjects must also agree to have an MRI scan for this research study if she/he has not had a recent scan that the study doctor decides can be used for this study.

Eligibility Criteria

This trial is for men and women over 55, either healthy or with Alzheimer's/Mild Cognitive Impairment. Healthy participants need a negative amyloid PET scan and an MMSE score of 28+. Those with Alzheimer's should have a positive amyloid PET scan and an MMSE score of 14-27. All must be part of the UPenn ADC cohort, informed about the study's nature, consent in writing, and follow guidelines.

Inclusion Criteria

I am 55 years old or older.
Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
A brain amyloid PET scan ≤ 1 year prior to enrollment in this study that is determined to be positive by the study PI.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Imaging and Blood Sampling

Participants undergo PET/CT scans using [18F]NOS and possibly [11C]PBR28, along with blood sampling

1 day
1-2 visits (in-person)

MRI Scan

Participants must have an MRI scan if a recent one is not available

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

Treatment Details

Interventions

  • [11C]PBR28
  • [18F]NOS
Trial Overview The study tests two brain imaging agents ([18F]NOS and [11C]PBR28) using PET/CT scans to understand brain inflammation in Alzheimer’s Disease/Mild Cognitive Impairment versus healthy subjects. Some may also join a sub-study comparing both tracers. Participants will undergo blood tests and possibly an MRI.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: AD/MCI or HC with Genetic PolymorphismExperimental Treatment1 Intervention
Sub-Study: Subjects have a specific genetic polymorphism andare diagnosed with Alzheimer's Disease (AD)/Mild Cognitive Imparment (MCI) or are healthy volunteers/controls (HC).
Group II: AD/MCI or HCExperimental Treatment1 Intervention
Main Study: Subjects are diagnosed with Alzheimer's Disease (AD)/Mild Cognitive Imparment (MCI) or are healthy volunteers/controls (HC).

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials
2,118
Recruited
45,270,000+

Findings from Research

The study successfully developed a new PET imaging tracer, [18F]FBAT, which can detect inducible nitric oxide synthase (iNOS) activity in a mouse model of neuroinflammation, indicating its potential as a biomarker for neuroinflammation.
In vivo imaging showed that [18F]FBAT accumulation was significantly higher in LPS-treated mice compared to controls, and this accumulation was reduced by an iNOS inhibitor, confirming the tracer's specificity for iNOS in neuroinflammatory conditions.
Automated Synthesis and Initial Evaluation of (4'-Amino-5',8'-difluoro-1'H-spiro[piperidine-4,2'-quinazolin]-1-yl)(4-[18F]fluorophenyl)methanone for PET/MR Imaging of Inducible Nitric Oxide Synthase.Yeh, SH., Huang, WS., Chiu, CH., et al.[2021]
The compound [(18)F]9 was identified as a promising PET tracer for imaging inducible nitric oxide synthase (iNOS), showing higher uptake in the lungs of mice with LPS-induced iNOS activation compared to control mice.
In vivo studies confirmed the specificity of [(18)F]9 for iNOS, as tracer uptake was significantly reduced when a known iNOS inhibitor was used, indicating its potential for accurate imaging of iNOS activation in inflammatory conditions.
Design and synthesis of 2-amino-4-methylpyridine analogues as inhibitors for inducible nitric oxide synthase and in vivo evaluation of [18F]6-(2-fluoropropyl)-4-methyl-pyridin-2-amine as a potential PET tracer for inducible nitric oxide synthase.Zhou, D., Lee, H., Rothfuss, JM., et al.[2021]
The study demonstrated that 18F-PBR-111 PET imaging can effectively identify neuroinflammation in specific brain regions of cuprizone-treated mice, indicating its potential as a marker for multiple sclerosis (MS) research.
Significant uptake of 18F-PBR-111 was observed in areas associated with neuroinflammation, such as the corpus callosum and striatum, and this uptake correlated with the presence of activated microglia, suggesting its utility for evaluating treatment responses in MS.
Assessment of 18F-PBR-111 in the Cuprizone Mouse Model of Multiple Sclerosis.Jewells, VL., Yuan, H., Merrill, JR., et al.[2021]

References

Automated Synthesis and Initial Evaluation of (4'-Amino-5',8'-difluoro-1'H-spiro[piperidine-4,2'-quinazolin]-1-yl)(4-[18F]fluorophenyl)methanone for PET/MR Imaging of Inducible Nitric Oxide Synthase. [2021]
Design and synthesis of 2-amino-4-methylpyridine analogues as inhibitors for inducible nitric oxide synthase and in vivo evaluation of [18F]6-(2-fluoropropyl)-4-methyl-pyridin-2-amine as a potential PET tracer for inducible nitric oxide synthase. [2021]
Assessment of 18F-PBR-111 in the Cuprizone Mouse Model of Multiple Sclerosis. [2021]
[18F]NOS PET Brain Imaging Suggests Elevated Neuroinflammation in Idiopathic Parkinson's Disease. [2023]
Development of Alzheimer's disease imaging agents for clinical studies. [2019]
Pharmacokinetic Analysis of 11C-PBR28 in the Rat Model of Herpes Encephalitis: Comparison with (R)-11C-PK11195. [2017]
Feasibility and dosimetry studies for 18F-NOS as a potential PET radiopharmaceutical for inducible nitric oxide synthase in humans. [2021]
In vivo molecular imaging of neuroinflammation in Alzheimer's disease. [2020]
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