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Disease-modifying vs symptomatic treatments: Splitting over lumping.

Kevin R Duque1, Joaquin A Vizcarra2, Emily J Hill1

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Clinical trials for neurodegenerative diseases fail by lumping patients. A shift to splitting patients into subtypes is vital for developing effective disease-modifying therapies and achieving precision medicine success.

Keywords:
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Area of Science:

  • Neuroscience
  • Genetics
  • Biomarker Discovery

Background:

  • Current disease-modifying therapy trials in neurodegeneration use a "lumping" approach, grouping diverse patients.
  • This "convergent" strategy has yielded successes for symptomatic treatments but failed for neuroprotective interventions.
  • Neurodegenerative disorders have varied biological drivers, necessitating a "splitting" approach for effective treatment.

Approach:

  • Develop aging cohorts independent of phenotype to guide biomarker discovery.
  • Validate divergence biomarkers that are present in some patients but absent in most.
  • Implement bioassay-based recruitment for disease-modifying trials to match therapies with recipients.

Key Points:

  • Precision medicine requires identifying distinct molecular/biological subtypes within neurodegenerative diseases.
  • Biomarker development should be guided by biology, moving from phenotype to biology.
  • Mendelian randomization studies can evaluate epidemiologic leads for pathogenetic potential before clinical trials.

Conclusions:

  • A paradigm shift from "lumping" to "splitting" is essential for advancing neurodegenerative disease modification.
  • Future efforts should focus on "proteinopenia" rather than solely "proteinopathy".
  • Matching patients to therapies based on individual biological drivers will improve treatment outcomes.