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Measuring Active Microglia in Progressive Multiple Sclerosis

NCT02207075 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2022-01-18

No results posted yet for this study

Summary

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.

Conditions

  • Secondary Progressive Multiple Sclerosis

Interventions

DRUG

[C11]PK-1195 PET scan

PET scan with tracer \[C11\]PK-1195

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Susan Gauthier, DO · Weill Medical College of Cornell University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2020-12-31
Completion
2020-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02207075 on ClinicalTrials.gov