Neuroinflammation Imaging for Alzheimer's Disease
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?
Is the treatment in the trial 'Neuroinflammation Imaging for Alzheimer's Disease' a promising treatment?
How does this treatment for Alzheimer's disease differ from other treatments?
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Imaging and Blood Sampling
Participants undergo PET/CT scans using [18F]NOS and possibly [11C]PBR28, along with blood sampling
MRI Scan
Participants must have an MRI scan if a recent one is not available
Follow-up
Participants are monitored for safety and effectiveness after imaging procedures
Treatment Details
Interventions
- [11C]PBR28
- [18F]NOS
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor