Clinical trial NCT02649985: PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases
Official title: Microglial Activation PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases
Conditions: Multiple Sclerosis
Alzheimer's Disease
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.
Interventions:
description: PET radiopharmaceutical
name: [F-18]PBR06
other_name: [F-18] PBR06
type: Drug
description: PET radiopharmaceutical
name: [C-11]PBR28
other_name: [C-11] PBR28
type: Drug
Study arms:
design_group_description: 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.<br/>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.
design_group_title: Relapsing-Remitting Multiple Sclerosis
design_group_type: Experimental
design_group_description: 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.
design_group_title: Progressive Multiple Sclerosis
design_group_type: Experimental
design_group_description: 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.
design_group_title: Alzheimer's Disease
design_group_type: Experimental
design_group_description: This group will serve as non disease population.
design_group_title: Healthy Control
design_group_type: Experimental
design_group_description: Subjects who have already been prescribed Ocrelizumab by their treating MS neurologist, but have not yet started the first Ocrelizumab infusion.<br/>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.
design_group_title: Multiple Sclerosis Ocrelizumab
design_group_type: Experimental
design_group_description: 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.
design_group_title: Multiple Sclerosis Foralumab
design_group_type: Experimental
design_group_description: Subjects who have already been prescribed steroids by their treating MS neurologist, but have not yet initiated treatment.<br/>Subjects will undergo two separate visits for [F-18]PBR06 PET scans: one before steroid treatment and one after steroid treatment.
design_group_title: Multiple Sclerosis Steroids Treatment
design_group_type: Experimental
Sponsor: The Brigham & Women's Hospital, Inc.
Collaborators: The Massachusetts General Hospital
Drug name mappings:
name: [11C]PBR-28
lang: EN
name: [18F]-PBR-06
lang: EN