Measuring Active Microglia in Progressive Multiple Sclerosis (NCT02207075) | Clinical Trial Compass
CompletedNot Applicable
Measuring Active Microglia in Progressive Multiple Sclerosis
United States50 participantsStarted 2014-07
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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Subjects will be withdrawn from the study if treatment is changed during the 24-month study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: 24 months
Trial details
NCT IDNCT02207075
SponsorWeill Medical College of Cornell University