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Measuring Active Microglia in Progressive Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02207075
Recruitment Status : Active, not recruiting
First Posted : August 1, 2014
Last Update Posted : May 27, 2020
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Brief 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.


Condition or disease Intervention/treatment
Secondary Progressive Multiple Sclerosis Radiation: [C11]PK-1195 PET scan

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Study Type : Observational
Estimated Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring Active Microglia in Progressive Multiple Sclerosis
Study Start Date : July 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Subjects with SPMS

Secondary progressive MS Subjects either untreated or on consistent treatment for six months prior to enrollment.

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.

Radiation: [C11]PK-1195 PET scan
PET scan with tracer [C11]PK-1195

Normal Control Subjects
Healthy Controls will have 2 baseline [C11]PK-1195 PET scans and 1 MRI.
Radiation: [C11]PK-1195 PET scan
PET scan with tracer [C11]PK-1195




Primary Outcome Measures :
  1. Measure the level of baseline and change of whole brain uptake of [11C]PK-11195 at 6, 12 and 24 months in SPMS subjects. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. To correlate the change in T2-hyperintense lesion volume at 6,12 and 24 months of with whole brain uptake of [11C]PK-11195 on PET (at the 6,12 and 24 months) in SPMS subjects. [ Time Frame: 24 months ]
  2. To correlate the change of conventional MRI measures of neuronal integrity (Gray Matter Fraction, White Matter Fraction, whole brain volume, T1-hypointense lesion volume) at 6,12 and 24 months with whole brain PET uptake of [11C]PK-11195 (at the 6,12 and [ Time Frame: 24 months ]
  3. To correlate the change in whole brain PET uptake of [11C]PK-11195 (at the 6,12 and 24 months) and level in disability, as measured by a change in EDSS at 6, 12, and 24 months in SPMS subjects. [ Time Frame: 24 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Approximately 36 subjects (with SPMS and controls) including screen failures will be enrolled regardless of gender
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02207075


Locations
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United States, New York
Weill Cornell Medical College
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Genzyme, a Sanofi Company
Investigators
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Principal Investigator: Susan Gauthier, DO Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02207075    
Other Study ID Numbers: 1309014365
First Posted: August 1, 2014    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Weill Medical College of Cornell University:
SPMS
Myelin Water Fraction
activated microglia
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases