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Adaptive trials and new designs.

C Wade1, S Apap Mangion1, J Chataway2

  • 1Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, Faculty of Brain Sciences, UCL Queen Square Institute of Neurology, University College London, London, United Kingdom.

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|April 2, 2026
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Summary
This summary is machine-generated.

Multi-arm multi-stage (MAMS) platform trials accelerate the evaluation of neurological therapeutics for neurodegenerative diseases. These adaptive designs improve efficiency, reduce costs, and enhance responsiveness to scientific progress in drug development.

Keywords:
Multiple sclerosisTrial design

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Area of Science:

  • Neuroscience
  • Clinical Trials
  • Pharmacology

Background:

  • Neurodegenerative diseases lack effective disease-modifying treatments.
  • Traditional clinical trial designs are inadequate for slowly progressive, heterogeneous neurological disorders.
  • Existing adaptive and multi-arm methods have limitations when used in isolated trials.

Purpose of the Study:

  • To introduce Multi-Arm Multi-Stage (MAMS) platform designs as a superior approach for neurological therapeutics.
  • To highlight the advantages of MAMS designs in addressing the limitations of traditional and isolated adaptive trials.
  • To showcase the potential of MAMS platforms in accelerating drug development for neurodegenerative diseases.

Main Methods:

  • MAMS platform designs evaluate multiple interventions concurrently against a shared control.
  • Incorporates interim analyses to discontinue non-efficacious treatment arms early.
  • Allows for the addition of new treatments and biomarkers within a continuous, phase-3-capable infrastructure.

Main Results:

  • MAMS platforms demonstrate feasibility and impact, drawing from oncology and infectious disease experience.
  • Emerging neurological MAMS trials (e.g., MND-SMART, ACT-PD, AD-SMART, OCTOPUS) are being implemented.
  • These trials accelerate therapeutic evaluation, reduce costs, and lessen participant burden.

Conclusions:

  • MAMS platform designs offer a powerful solution for evaluating neurological therapeutics.
  • These adaptive trial infrastructures enhance efficiency and responsiveness to scientific advancements.
  • MAMS trials are crucial for developing effective treatments for neurodegenerative diseases.