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New treatment option for Multiple Sclerosis
Official title PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases
ClinicalTrials.gov ID: NCT02649985
What this study is testing
What is [F-18]PBR06?
[F-18]PBR06 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for multiple sclerosis.
Also referred to as [F-18] PBR06.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Male and female people age 18 to 70 years. For Alzheimer's Disease patients and healthy controls, the age range is going to be 18 to 85 years. This...
- For RRMS, it needs to be active, which is defined as at least one relapse in the past 12 months, at least one gadolinium enhancing lesion on MRI...
- For SPMS, deterioration in EDSS score in the last year is required.
- For the people in the Ocrelizumab arm, only the people who have already been prescribed Ocrelizumab by their treating MS neurologist but have not yet...
- For the Foralumab arm, patients enrolled in approved IRB protocols (2021P000105, 2022P000005, 2022P001075) will be enrolled.
You likely can't join if
- Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
- Individuals with bipolar disease and schizophrenia
- Concurrent medical conditions that contraindicate study procedures.
- Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment.
- Claustrophobia
- Non-MRI compatible implanted devices
See the full eligibility criteria
- Male and female people age 18 to 70 years. For Alzheimer's Disease patients and healthy controls, the age range is going to be 18 to 85 years. This is because Alzheimer's disease people are usually older and it'd be...
- For RRMS, it needs to be active, which is defined as at least one relapse in the past 12 months, at least one gadolinium enhancing lesion on MRI within 12 months of enrollment or at least one new FLAIR bright lesion on...
- For SPMS, deterioration in EDSS score in the last year is required.
- For the people in the Ocrelizumab arm, only the people who have already been prescribed Ocrelizumab by their treating MS neurologist but have not yet started the first infusion, will be included.
- For the Foralumab arm, patients enrolled in approved IRB protocols (2021P000105, 2022P000005, 2022P001075) will be enrolled.
- For the steroids arm, only people who have already been prescribed steroids by their treating MS neurologist, but have not yet initiated treatment, will be included.
- AD people with MMSE score of 20-26.
- people willing to undergo PET and MRI imaging
- people willing and able to give informed consent
- Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
- Individuals with bipolar disease and schizophrenia
- Concurrent medical conditions that contraindicate study procedures.
- Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment.
- Claustrophobia
- Non-MRI compatible implanted devices
- For the Ocrelizumab arm, people already on Ocrelizumab will be excluded. 8. For the steroids arm, people who have already started steroid treatment will be excluded. 9\. For the Ocrelizumab arm, steroids arm, and...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.