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Measuring Active Microglia in Progressive Multiple Sclerosis

NCT02207075

CompletedN/A

Sponsor: Weill Medical College of Cornell University

Conditions: Secondary Progressive Multiple Sclerosis

Interventions: [C11]PK-1195 PET scan

Countries: United States

This is pilot study designed to quantifying the innate immune inflammatory burden in a cohort of secondary progressive multiple sclerosis subjects. Innate immunity is recognized as a major cause of tissue injury in central nervous system (CNS) disease. Our hypothesis is that the innate immune response is heightened in SPMS as compared to healthy controls (HC's) and this activity increases over time and correlates with ongoing neuronal loss and disability. The investigators will test this hypothesis by using highly specific molecular imaging techniques, specifically PET, in conjunction with high field MRI. The investigators will utilize the PET radioligand \[11C\]PK11195 which will be used as a marker of activated macrophages/microglia. The investigators will correlate \[11C\]PK11195 uptake with conventional measures of inflammation and neuronal integrity on high-resolution MRI. SPMS subjects will have two baseline \[11C\]PK-11195 PET scans (separated by 24 to 72 hours, test-retest) and subsequent scans at 6, 12 and 24 months. SPMS Subjects will have brain MRI's at baseline, 6, 12 and 24 months. Healthy Controls will have 2 baseline PET scans and one MRI.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Subjects age 18-80
* Secondary progressive MS subjects either untreated or on consistent treatment for six-months prior to enrollment
* Norman Controls

Exclusion Criteria:

* Subjects pregnant or woman of child-bearing age not utilizing effective birth control
* Primary progressive MS subjects
* Relapsing remitting MS subjects
* Unstable SPMS subject for which treatment change within the 24 months is likely

Age-Healthy controls will be excluded if have any of the following medical conditions:

* Any central nervous system disorder
* Any systemic auto-immune disorder
* Pregnant or woman of child-bearing age not utilizing effective birth control

Subjects will be withdrawn from the study if treatment is changed during the 24-month study

Locations (1)

New York, New York, United States