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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT02649985
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • [F-18]PBR06 — DRUG
    PET radiopharmaceutical
  • [C-11]PBR28 — DRUG
    PET radiopharmaceutical

Study Details

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.

Key Dates

Start date
May 2, 2016
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Relapsing-Remitting Multiple Sclerosis
    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. 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.
  • Experimental: Progressive Multiple Sclerosis
    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.
  • Experimental: Alzheimer's Disease
    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.
  • Experimental: Healthy Control
    This group will serve as non disease population.
  • Experimental: Multiple Sclerosis Ocrelizumab
    Subjects who have already been prescribed Ocrelizumab by their treating MS neurologist, but have not yet started the first Ocrelizumab infusion. 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.
  • Experimental: Multiple Sclerosis Foralumab
    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.
  • Experimental: Multiple Sclerosis Steroids Treatment
    Subjects who have already been prescribed steroids by their treating MS neurologist, but have not yet initiated treatment. Subjects will undergo two separate visits for \[F-18\]PBR06 PET scans: one before steroid treatment and one after steroid treatment.

Primary Outcome Measure

Standardized uptake values (SUV)/Standardized uptake value ratios (SUVR) [ Time Frame: Baseline, 3 months, and 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham MS Center, 60 Fenwood RoadBostonMassachusetts02115
Steven Cicero
[email protected]
617-264-3044

Find similar trials in Boston, MA

By condition
Alzheimer's diseaseMultiple sclerosis
By specialty
NeurologyDementia careBrain disordersGeriatricsAutoimmune disease
By research site
Brigham MS Center, 60 Fenwood Road· Boston, MA

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