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

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ClinicalTrials.gov Identifier: NCT03983252
Recruitment Status : Not yet recruiting
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Collaborator:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Tarun Singhal, Brigham and Women's Hospital

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: [F-18]PBR06 Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Effect of Alemtuzumab on Microglial Activation Assessed Using Novel [F-18]-Based Positron Emission Tomography (PET) Ligand in Multiple Sclerosis
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab

Arm Intervention/treatment
Experimental: Relapsing Remitting Multiple Sclerosis starting Alemtuzumab

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
PET radiopharmaceutical
Other Name: [18F]PBR06




Primary Outcome Measures :
  1. PET Uptake/Standardized uptake value ratio (SUVR) change [ Time Frame: baseline and 18 months ]
    PET outcome measure change at 18 months from baseline


Secondary Outcome Measures :
  1. PET Uptake/Standardized uptake value ratio (SUVR) change [ Time Frame: baseline and 6 months ]
    PET outcome measure change at 6 months from baseline

  2. T2/FLAIR lesion load change [ Time Frame: baseline and 18 months ]
    MRI outcome measure change at 18 months from baseline

  3. Whole brain/deep gray matter atrophy change [ Time Frame: baseline and 18 months ]
    MRI outcome measure change at 18 months from baseline

  4. Expanded Disability Status Scale (EDSS) change [ Time Frame: baseline and 18 months ]
    Clinical outcome measure change at 18 months from baseline; Scale Range: 0-10; Higher values represent worse outcomes

  5. Timed 25-foot walk (T25FW) change [ Time Frame: baseline and 18 months ]
    Clinical outcome measure change at 18 months from baseline

  6. Modified Fatigue Impact Scale (MIFS) change [ Time Frame: baseline and 18 months ]
    Clinical outcome measure change at 18 months from baseline; Physical subscale range: 0-36; Cognitive subscale range: 0-40; Psychosocial subscale range: 0-8; Total MFIS Score scale range (Subscales Summed): 0-84; Higher values represent worse outcomes

  7. Minimal Assessment of Cognitive Function in MS (MACFIMS) change [ Time Frame: baseline and 18 months ]
    Clinical outcome measure change at 18 months from baseline



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03983252


Contacts
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Contact: Tarun Singhal, MD 203-804-5131 tsinghal@bwh.harvard.edu

Locations
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United States, Massachusetts
Partners MS Center, 60 Fenwood Road Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Steven Cicero    617-264-3044    scicero@bwh.harvard.edu   
Sponsors and Collaborators
Brigham and Women's Hospital
Genzyme, a Sanofi Company
Investigators
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Principal Investigator: Tarun Singhal, MD Brigham and Women's Hospital

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Responsible Party: Tarun Singhal, Assistant Professor of Neurology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT03983252     History of Changes
Other Study ID Numbers: 2018A019732
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Alemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents