Effect of Alemtuzumab on Microglial Activation Positron Emission Tomography (PET) in Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
Reason given: The study was terminated without recruitment.
What was tested
Treatment tested
- [F-18]PBR06
What it measured
Main measures
PET Uptake/Standardized uptake value ratio (SUVR) change
baseline and 18 months
Other measures (7)
PET Uptake/Standardized uptake value ratio (SUVR) change
baseline and 6 months
T2/FLAIR lesion load change
baseline and 18 months
MRI lesionsWhole brain/deep gray matter atrophy change
baseline and 18 months
MRI lesionsBrain volume lossExpanded Disability Status Scale (EDSS) change
baseline and 18 months
Disability progressionTimed 25-foot walk (T25FW) change
baseline and 18 months
Disability progressionWalking and mobilityModified Fatigue Impact Scale (MIFS) change
baseline and 18 months
Thinking and memoryFatigueMinimal Assessment of Cognitive Function in MS (MACFIMS) change
baseline and 18 months
Thinking and memory
Who could take part
Relapsing MS · 18 to 60
Inclusion Criteria: * Patients with Relapsing Remitting Multiple Sclerosis (RRMS) (defined by International Panel Criteria) * Age 18-60 years * Enrolled to start treatment with alemtuzumab Exclusion Criteria: * Relapse/Corticosteroid treatment in the past 4 weeks to avoid transient effects on imaging * Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse. * Individuals with bipolar disease and schizophrenia * Concurrent medical conditions that contraindicate study procedures. * Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment. * Claustrophobia * Non-MRI compatible implanted devices * Low affinity binder
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
Specific Aims The specific aims of the study are: * Primary Objective: To assess the effect of alemtuzumab on microglial activation in MS patients. The hypothesis is that alemtuzumab reduces microglial activation in MS, which may mediate its effect on reducing conversion of RRMS patients to SPMS, and its effects on cognition, including cognitive fatigue. * Secondary Objective: To determine the time course of effect of alemtuzumab on microglial activation. The hypothesis is that alemtuzumab reduces microglial activation at 6 months after initiation of treatment and this effect persists and is accentuated at 18 years, i.e. after administration of the second course
Papers
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History
Started
Dec 2021
Main results due
May 2024
Finished
May 2024
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