Microglial Activation PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases
Brigham and Women's Hospital
Summary
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.
Description
Four groups of subjects will be recruited: 1. 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. Subjects meeting the definition for SPMS by International Panel Criteria and who have demonstrated deterioration in Expanded Disability Status Scale (EDSS) score in last 1 year 3. Subjects meeting the definition for probable AD based on National Institute of Neurological and Communic…
Eligibility
- Age range
- 18–85 years
- Sex
- All
- Healthy volunteers
- Yes
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 b…
Interventions
- Drug[F-18]PBR06
PET radiopharmaceutical
- Drug[C-11]PBR28
PET radiopharmaceutical
Location
- Brigham MS Center, 60 Fenwood RoadBoston, Massachusetts