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Related Experiment Video

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Treatment Selection and Prioritization for the EJS ACT-PD MAMS Trial Platform.

Cristina Gonzalez-Robles1, Dilan Athauda1, Thomas R Barber1

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Movement Disorders : Official Journal of the Movement Disorder Society
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PubMed
Summary
This summary is machine-generated.

The Edmond J. Safra Accelerating Clinical Trials in Parkinson Disease (EJS ACT-PD) initiative selected three drugs, telmisartan, terazosin, and ursodeoxycholic acid, for its Parkinson's disease clinical trial platform.

Keywords:
Parkinson's diseaseadaptive clinical trialmethodologyneuroprotectionneuroprotective agents

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Area of Science:

  • Neuroscience
  • Clinical Pharmacology
  • Drug Development

Background:

  • Parkinson's disease (PD) currently lacks approved disease-modifying therapies (DMTs).
  • The Edmond J. Safra Accelerating Clinical Trials in Parkinson Disease (EJS ACT-PD) initiative aims to accelerate the evaluation of potential DMTs.
  • This initiative employs a multi-arm multistage (MAMS) trial design to efficiently test multiple treatments against a common placebo.

Purpose of the Study:

  • To detail the systematic process used for selecting treatments for the EJS ACT-PD clinical trial platform.
  • To outline a robust methodology for identifying and prioritizing drug candidates for Parkinson's disease.

Main Methods:

  • A Treatment Selection Working Group (TSWG) utilized literature reviews, related initiatives, and expert input to identify potential compounds.
  • Compounds were categorized by mechanism (mitochondrial, lysosomal, protein, inflammation, other) and evaluated using "Go/No-Go" criteria and a scoring system.
  • A multi-stage prioritization process involved expert scoring, dossier preparation, and consideration of practical/logistical factors by the Steering Committee (SC).

Main Results:

  • Out of 293 identified interventions, 52 met the "Go/No-Go" criteria and were scored.
  • Dossiers for the 14 highest-ranked compounds were reviewed by the SC.
  • Telmisartan, terazosin, and ursodeoxycholic acid were chosen as the initial interventions for the trial.

Conclusions:

  • Selecting disease-modifying therapies for Parkinson's disease MAMS trials necessitates balancing scientific evidence with practical considerations.
  • The presented drug selection system provides a robust framework applicable to similar clinical trial initiatives.
  • This systematic approach aids in advancing the development of novel Parkinson's disease treatments.