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Imaging Outcomes for Phase 2 Trials Targeting Compartmentalized Inflammation.

María I Gaitán¹, Rocio V Marquez², Jeremias Ayerbe²

¹National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.

Multiple Sclerosis (Houndmills, Basingstoke, England)

|December 11, 2024

Summary

This review explores advanced imaging for multiple sclerosis (MS) trials. New methods better capture brain inflammation, improving treatment efficacy assessment for this chronic neurological disease.

Keywords:

Phase 2 trials compartmentalized inflammation multiple sclerosis outcome measure

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Area of Science:

Neuroimaging
Clinical Trials
Immunology

Background:

Current MRI outcomes in multiple sclerosis (MS) trials primarily detect peripheral inflammation effects.
Existing methods fail to capture widespread, compartmentalized inflammation within the central nervous system, particularly behind a closed blood-brain barrier.

Purpose of the Study:

To review novel imaging outcome measures for assessing compartmentalized inflammation in Phase 2 MS clinical trials.
To identify emerging imaging technologies as surrogate markers for chronic active lesions, meningeal inflammation, and innate immune activation.

Main Methods:

Literature review of imaging outcome measures in Phase 2 multiple sclerosis clinical trials.
Analysis of emerging imaging technologies and their potential application in assessing central nervous system inflammation.

Main Results:

Traditional MRI outcomes (new/enhancing white matter lesions) are insufficient for capturing key inflammatory processes in MS.
Emerging imaging techniques show promise for detecting compartmentalized inflammation, including chronic active lesions and meningeal involvement.

Conclusions:

Integrating advanced imaging outcomes into Phase 2 MS trials can provide more accurate treatment efficacy assessments.
Novel imaging strategies are crucial for developing more effective therapies for multiple sclerosis by better understanding disease pathology.