Effect of Alemtuzumab on Microglial Activation Positron Emission Tomography (PET) in Multiple Sclerosis

• Status: Not yet recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Alemtuzumab

Criteria

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