PET Brain Imaging for Alzheimer's Disease and Multiple Sclerosis
(MAPET Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the activity of certain brain cells, called microglia, in people with Multiple Sclerosis (MS) and Alzheimer's Disease (AD) compared to healthy individuals. Researchers will use special PET scans with [C-11]PBR28 and [F-18]PBR06 (radioactive tracers) to determine if brain activity patterns differ between these conditions and whether this activity correlates with disease severity or other issues like pain or depression. Participants with active Relapsing-Remitting MS, those with Secondary Progressive MS, and individuals with mild Alzheimer's might be suitable, especially if they are willing to undergo PET and MRI scans and have not yet started specific treatments like Ocrelizumab or steroids. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking discoveries.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are in the Ocrelizumab or steroids arm, you should not have started these treatments yet.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Studies have shown that both [C-11]PBR28 and [F-18]PBR06 are generally well-tolerated in PET scans. Research indicates that [C-11]PBR28 has been safely used to detect inflammation and other brain changes without significant side effects. In healthy individuals, studies have confirmed the radiation safety of [C-11]PBR28, making it reliable for imaging purposes.
For [F-18]PBR06, early findings suggest it is also safe for brain imaging, particularly in Alzheimer's Disease. Animal studies have shown that [F-18]PBR06 can effectively highlight brain changes with no major safety concerns reported. This radiotracer has been used to assess microglial activity, which is part of the brain's immune response.
Both radiotracers are used in PET imaging to examine the brain and have shown no severe adverse events in available studies. While not yet approved for all uses, their safety profiles in research settings are reassuring.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this trial because it uses PET brain imaging with tracers like [C-11]PBR28 and [F-18]PBR06 to study neurological and neuropsychiatric diseases. Unlike traditional methods that might rely solely on clinical symptoms or MRI alone, these PET scans can provide a more detailed look at brain inflammation and activity. By comparing different tracers, the trial aims to identify which is better at highlighting disease activity. This could lead to more precise diagnosis and monitoring of conditions like Multiple Sclerosis and Alzheimer's Disease, potentially improving treatment approaches in the future.
What evidence suggests that this trial's treatments could be effective for Multiple Sclerosis and Alzheimer's Disease?
This trial will evaluate different treatments for multiple sclerosis, including Foralumab and Ocrelizumab. Research has shown that Foralumab can calm overactive brain cells and stabilize the condition in people with multiple sclerosis. This treatment might slow the disease and help manage symptoms more effectively. Meanwhile, long-term studies have demonstrated that Ocrelizumab significantly reduces relapses and slows the progression of disability in relapsing multiple sclerosis. After 10 years, most patients using Ocrelizumab did not need a walking aid. Both treatments have shown promise in managing multiple sclerosis by controlling the disease and its progression.678910
Who Is on the Research Team?
Tarun Singhal, MD
Principal Investigator
Brigham and Women's Hospital
Are You a Good Fit for This Trial?
This trial is for individuals with active Relapsing Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis showing recent deterioration, or Alzheimer's Disease with certain cognitive scores. Participants must be willing to undergo PET and MRI scans and able to consent. Those already prescribed Ocrelizumab but not yet started treatment may also join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pilot Phase
8 subjects with RRMS undergo both [C-11]PBR28 PET scan and [F-18]PBR06 PET scan
Main Study Phase
Subjects undergo [F-18]PBR06 PET scans and 3-Tesla MRI of the brain
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- [C-11]PBR28
- [F-18]PBR06
Trial Overview
The study tests if two PET scan tracers, [F-18]PBR06 and [C-11]PBR28, can show microglial activation (brain inflammation) in patients with MS or AD compared to healthy people. It will check the distribution of this activation and its correlation with disease severity.
How Is the Trial Designed?
7
Treatment groups
Experimental Treatment
Subjects meeting the definition for RRMS by the International Panel Criteria, who are active, as defined by at least one MS relapse in the past 12 months, at least one gadolinium enhancing lesion on a MRI within 12 months of enrollment, or at least one new FLAIR bright lesion on MRI within 6 months of enrollment. The study will be performed in two phases. In the early pilot phase, 8 subjects with multiple sclerosis will undergo both \[C-11\]PBR28 PET scan and \[F-18\]PBR06 PET scan. At the end of this phase, a formal interim analysis will be performed and if imaging characteristics of \[F-18\]PBR06 are found non-inferior to or better than \[C-11\]PBR28, the rest of the study will be completed using \[F-18\]PBR06. On the other hand, if \[F-18\]PBR06 is found to be inferior to \[C-11\]PBR28, the rest of the study will be pursued using \[C-11\]PBR28.
Subjects meeting the definition for SPMS/PPMS (Primary Progressive Multiple Sclerosis) by International Panel Criteria and who have demonstrated deterioration in EDSS score in last 1 year.
Subjects who have already been prescribed steroids by their treating MS neurologist, but have not yet initiated treatment. Subjects will undergo two separate visits for \[F-18\]PBR06 PET scans: one before steroid treatment and one after steroid treatment.
Subjects who have already been prescribed Ocrelizumab by their treating MS neurologist, but have not yet started the first Ocrelizumab infusion. Subjects will undergo two separate visits for \[F-18\]PBR06 PET scans, once before starting Ocrelizumab and the second visit 3 months after completion of the initial Ocrelizumab doses.
Subjects will undergo 3 separate visits for \[F-18\]PBR06 PET scans, once before initiating treatment with Foralumab, the second visit 3 months after starting Foralumab, and the third visit 6 months after starting Foralumab.
This group will serve as non disease population.
Subjects meeting the definition for probable AD based on NINDS-ADRDA criteria. In terms of severity of disease, the investigators will select subjects with mild AD, as defined by Mini-Mental Status Examination (MMSE) score of 20-26.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Massachusetts General Hospital
Collaborator
Citations
1.
tizianalifesciences.com
tizianalifesciences.com/tiziana-life-sciences-announces-the-peer-reviewed-publication-of-clinical-study-results-for-intranasal-foralumab/Tiziana Life Sciences Announces the Peer-Reviewed ...
Currently, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized ...
2.
medcentral.com
medcentral.com/neurology/ms/nasal-foralumab-shows-efficacy-in-nonactive-secondary-progressive-msNasal Foralumab Shows Efficacy in Nonactive Secondary ...
Tiziana Life Sciences' investigational monoclonal antibody could change how progressive multiple sclerosis is managed.
3.
tizianalifesciences.com
tizianalifesciences.com/tiziana-life-sciences-announces-comprehensive-positive-results-from-study-of-nasal-foralumab-in-patients-with-multiple-sclerosis/Tiziana Life Sciences Announces Comprehensive Positive ...
This comprehensive study demonstrated that nasal foralumab was safe, induced potent regulatory immune responses, reduced microglial activation, and stabilized ...
Foralumab Nasal Spray May Offer New Hope for MS ...
A nasal spray called foralumab may help slow multiple sclerosis progression and help MS patients manage symptoms. Learn how this research ...
Real‐world evaluation of ocrelizumab in multiple sclerosis
Real‐world effectiveness data for ocrelizumab were consistently favorable, with reductions in relapse rate and disease progression rates similar ...
[11C]PBR28 radiotracer kinetics are not driven by alterations ...
We demonstrate that [ 11 C]PBR28 signal elevations in chronic low back pain patients are not accompanied, in the same regions, by increases in cerebral blood ...
Kinetic analysis in healthy humans of a novel positron ...
Having confirmed the radiation safety of [11C]PBR28, we sought in the current study to evaluate the ability of this radioligand to quantify PBRs ...
Imaging the brain's immune response to alcohol with ... - PMC
Imaging featured a baseline [11C]PBR28 scan followed by an oral laboratory alcohol challenge over 90 min. An hour later, a second [11C]PBR28 ...
an [11C]-PBR28 blocking study | European Journal of Nuclear ...
Dynamic emission data were acquired continuously for 90 min following the injection of [11C]PBR28. PET data were acquired in three-dimensional ...
Definition of carbon C 11 PBR-28 - NCI Drug Dictionary
Upon PET, carbon C 11 can be detected and TSPO-expressing cells can be visualized. This can facilitate detection of inflammatory sites and cancer cells. TSPO, ...
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