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PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases

Microglial Activation PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, PET scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "In addition, the investigators hypothesize that \[F-18\]PBR06-PET scans will be at least as good as \[C-11\]PBR28-PET scans, the current gold standard."
  • "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, or at least one gadolinium enhancing lesion on Magnetic Resonance Imaging (MRI) within 3 months of enrollment. 2."
  • "In the early pilot phase, 8 subjects with RRMS will undergo both \[C-11\]PBR28 PET scan and \[F-18\]PBR06 PET scan."
  • "All subjects will also undergo 3-Tesla (3T) MRI of the brain."
  • "Subject Safety: Subject monitoring during MRI and PET scans will be performed using a 2-way intercom system between the scanner operator and subject and by visual monitoring of the subject through the window into the scan room (the subject is visible to the operator at all times)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study uses PET brain scans to look for active immune cells in the brain in people with multiple sclerosis (MS) or Alzheimer's disease and compare them with healthy people. It also tests whether one PET scan method works at least as well as another in people with relapsing-remitting MS.

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. A pilot substudy aims to establish the non-inferiority of \[F-18\]PBR06 as compared with Carbon-11 \[C-11\] labeled "Peripheral Benzodiazepine Receptor 28" (PBR28) PET in patients with RRMS. Hypothesis: The working hypothesis is that there is microglial activation in multiple sclerosis and Alzheimer's disease as compared to healthy controls and that the pattern/ regional distribution of microglial activation is different in Multiple Sclerosis (MS) versus AD and correlates with disease severity and comorbidities. In addition, the investigators hypothesize that \[F-18\]PBR06-PET scans will be at least as good as \[C-11\]PBR28-PET scans, the current gold standard.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Ages 18–70 for people with MS, or 18–85 for people with Alzheimer's disease or healthy volunteers.
  • For relapsing-remitting MS: a flare-up in the past 12 months, an MRI spot that lights up with dye within 12 months, or a new bright spot on a certain MRI scan within 6 months.
  • For secondary progressive MS: a worse score on the EDSS, a scale that measures disability, in the past year.
  • For the ocrelizumab or steroid groups: your MS doctor must have prescribed that treatment, but you must not have started it yet.
  • For the foralumab group: you must be enrolled in one of these approved study plans: 2021P000105, 2022P000005, or 2022P001075.
  • For Alzheimer's disease: a score of 20–26 on the MMSE, a test of memory and thinking.
  • Willing to have PET and MRI scans.
  • Willing and able to give informed consent, meaning you understand the study and agree to join.

Who can't join

  • Another known brain or nerve disorder, a past head injury, or substance abuse.
  • Bipolar disorder or schizophrenia.
  • A medical condition that makes study procedures unsafe.
  • Pregnant, breastfeeding, trying to become pregnant, or thinking you may be pregnant.
  • Fear of tight or closed spaces.
  • An implanted device that is not safe for MRI scans.
  • For the ocrelizumab or steroid groups: you have already started that group's treatment.
  • For the ocrelizumab, steroid, or long-term follow-up groups: an abnormal blood creatinine level, a measure of kidney function.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Male and female subjects 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 subjects are usually older and it'd be difficult to recruit Alzheimer's patients who are younger than 70 years. Multiple Sclerosis, on the other hand, is a disease of a younger population. 2. 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 MRI within 6 months of enrollment. 3. For SPMS, deterioration in EDSS score in the last year is required. 4. For the subjects in the Ocrelizumab arm, only the subjects who have already been prescribed Ocrelizumab by their treating MS neurologist but have not yet started the first infusion, will be included. 5. For the Foralumab arm, patients enrolled in approved IRB protocols (2021P000105, 2022P000005, 2022P001075) will be enrolled. 6. For the steroids arm, only subjects who have already been prescribed steroids by their treating MS neurologist, but have not yet initiated treatment, will be included. 7. AD subjects with MMSE score of 20-26. 8. Subjects willing to undergo PET and MRI imaging 9. Subjects willing and able to give informed consent Exclusion Criteria: 1. Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse. 2. Individuals with bipolar disease and schizophrenia 3. Concurrent medical conditions that contraindicate study procedures. 4. 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. 5. Claustrophobia 6. Non-MRI compatible implanted devices 7. For the Ocrelizumab arm, subjects already on Ocrelizumab will be excluded. 8. For the steroids arm, subjects who have already started steroid treatment will be excluded. 9\. For the Ocrelizumab arm, steroids arm, and longitudinal arm, subjects with abnormal serum creatinine will be excluded.

Study sites (1)

MA