Actively Recruiting
PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases
Led by Brigham and Women's Hospital · Updated on 2026-01-28
250
Participants Needed
1
Research Sites
608 weeks
Total Duration
On this page
Sponsors
B
Brigham and Women's Hospital
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PET Brain Imaging in Multiple Sclerosis, Alzheimer's Disease, and Other Neurological and Neuropsychiatric Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects age 18 to 70 years for Multiple Sclerosis; 18 to 85 years for Alzheimer's Disease and healthy controls
- Active Relapsing Remitting Multiple Sclerosis with at least one relapse in past 12 months or recent MRI evidence of active lesions
- Secondary Progressive Multiple Sclerosis with deterioration in disability score in last year
- Subjects prescribed Ocrelizumab by their neurologist but not yet started treatment
- Subjects enrolled in approved IRB protocols for Foralumab treatment
- Subjects prescribed steroids by their neurologist but not yet started treatment
- Alzheimer's Disease subjects with Mini-Mental Status Examination score between 20 and 26
- Willingness to undergo PET and MRI imaging
- Ability and willingness to provide informed consent
You will not qualify if you...
- Known alternate neurological disorders, previous head injury, or substance abuse
- Diagnosis of bipolar disorder or schizophrenia
- Medical conditions that contraindicate study procedures
- Women who are pregnant, nursing, or planning pregnancy
- Claustrophobia
- Presence of non-MRI compatible implanted devices
- Subjects already on Ocrelizumab treatment
- Subjects who have already started steroid treatment
- Subjects with abnormal serum creatinine if in Ocrelizumab, steroids, or longitudinal arms
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Brigham MS Center, 60 Fenwood Road
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
T
Tarun Singhal, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
7
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