RecruitingPhase 1Phase 2NCT02649985

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


Sponsor

Brigham and Women's Hospital

Enrollment

250 participants

Start Date

May 2, 2016

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special type of brain scan called a PET scan to look at specific markers of inflammation and abnormal protein buildup in the brains of people with multiple sclerosis (MS), Alzheimer's disease, and other neurological conditions, helping researchers better understand how these diseases progress. **You may be eligible if...** - You have been diagnosed with multiple sclerosis, Alzheimer's disease, or another neurological condition being studied - You are willing to undergo a PET brain scan - You may also be eligible as a healthy volunteer for comparison purposes - You meet the age and health requirements of the study **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had significant radiation exposure recently - You have metal implants that could interfere with scanning - You have kidney or liver problems that affect how your body processes the scan's imaging agent - You have claustrophobia or cannot lie still during the scan Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[F-18]PBR06

PET radiopharmaceutical

DRUG[C-11]PBR28

PET radiopharmaceutical


Locations(1)

Brigham MS Center, 60 Fenwood Road

Boston, Massachusetts, United States

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NCT02649985


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