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Drug Development.

Pieter Jelle Visser1, Pallavi Sachdev2, Satya Saxena2

  • 1Alzheimer Center Amsterdam, Neurology, Vrije Universiteit Amsterdam, Amsterdam UMC location VUmc, Amsterdam, Netherlands.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 26, 2025
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Researchers identified five Alzheimer's disease (AD) molecular subtypes in an independent clinical trial cohort. This confirms subtype robustness, enabling personalized medicine and combination therapies for AD.

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Area of Science:

  • Neuroscience
  • Proteomics
  • Biomarker Discovery

Background:

  • Alzheimer's disease (AD) presents significant molecular heterogeneity, complicating treatment development.
  • Understanding AD subtypes is crucial for developing effective therapies and improving patient outcomes.
  • Previous research identified five distinct AD molecular subtypes based on protein alterations.

Purpose of the Study:

  • To validate the identified AD molecular subtypes in an independent cohort of early AD patients from a clinical trial.
  • To assess the replicability of previously defined AD subtypes using cerebrospinal fluid (CSF) proteomic data.
  • To investigate the amyloid specificity of these molecular subtypes.

Main Methods:

  • Cerebrospinal fluid (CSF) samples from 202 individuals (101 amyloid-positive, 101 amyloid-negative) in a Phase 3 elenbecestat trial were analyzed.
  • 16-plex tandem mass tag (TMT) mass spectrometry was employed for protein analysis.
  • A random forest classifier, trained on a discovery cohort, was used to classify individuals into one of the five AD subtypes.

Main Results:

  • All five AD molecular subtypes were identified in the amyloid-positive group.
  • The distribution of subtypes included hyperplasticity (s1, 44%), innate immune activation (s2, 20%), RNA dysregulation (s3, 1%), choroid plexus dysfunction (s4, 18%), and blood-brain barrier dysfunction (s5, 17%).
  • Protein level comparisons largely replicated previous findings, with SMOC1 levels significantly higher in amyloid-positive individuals.

Conclusions:

  • The successful replication of the five AD molecular subtypes in an independent clinical cohort validates their robustness.
  • These findings support the potential for developing personalized medicine approaches for Alzheimer's disease.
  • The identified subtypes pave the way for novel combination therapy strategies in AD treatment.