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

NCT03983252 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: 2018A019732
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• PET Uptake/Standardized uptake value ratio (SUVR) change

  PET outcome measure change at 18 months from baseline

  baseline and 18 months

Secondary Outcomes (7)

• PET Uptake/Standardized uptake value ratio (SUVR) change

  baseline and 6 months

• T2/FLAIR lesion load change

  baseline and 18 months

• Whole brain/deep gray matter atrophy change

  baseline and 18 months

• Expanded Disability Status Scale (EDSS) change

  baseline and 18 months

• Timed 25-foot walk (T25FW) change

  baseline and 18 months

Study Arms (1)

Relapsing Remitting Multiple Sclerosis starting Alemtuzumab

EXPERIMENTAL

Patients with Relapsing Remitting Multiple Sclerosis (RRMS) (defined by International Panel Criteria), age 18-60 years, enrolled to start treatment with alemtuzumab. Subjects will undergo \[F-18\]PBR06 PET scans at baseline, 6 months and 18 months.

Drug: [F-18]PBR06

Interventions

[F-18]PBR06 DRUG

PET radiopharmaceutical

Also known as: [18F]PBR06

Relapsing Remitting Multiple Sclerosis starting Alemtuzumab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Relapsing Remitting Multiple Sclerosis (RRMS) (defined by International Panel Criteria)
• Age 18-60 years
• Enrolled to start treatment with alemtuzumab

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Genzyme, a Sanofi Company: collaborator

Study Sites (1)

Partners MS Center, 60 Fenwood Road

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

N-fluoroacetyl-N-(2,5-dimethoxybenzyl)-2-phenoxyaniline

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tarun Singhal, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: May 31, 2019
• First Posted: June 12, 2019
• Study Start: December 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)