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Drug Development.

Lon S S Schneider1,2,3, Jorge J Llibre-Guerra4, David B Clifford5

  • 1Alzheimer's Disease Research Center, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.

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Summary
This summary is machine-generated.

This study investigates etalanetug, an anti-tau therapy, combined with lecanemab for dominantly inherited Alzheimer's disease (DIAD). The trial aims to assess etalanetug's efficacy in reducing tau spread and improving cognitive outcomes in DIAD patients.

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Area of Science:

  • Neuroscience
  • Pharmacology
  • Clinical Trials

Background:

  • Alzheimer's disease (AD) involves amyloid-beta plaques and tau tangles.
  • Tau protein, crucial for microtubule stability, can form toxic aggregates in AD.
  • Targeting tau's microtubule-binding region (MTBR) may inhibit aggregation and neurodegeneration.

Purpose of the Study:

  • To investigate the efficacy of etalanetug (E2814), an anti-tau monoclonal antibody, in combination with lecanemab.
  • To determine the role of tau in disease biology and progression within dominantly inherited Alzheimer's disease (DIAD).
  • To evaluate potential benefits of etalanetug in patients with DIAD, using lecanemab as background therapy.

Main Methods:

  • Phase II/III randomized, double-blinded, placebo-controlled DIAN-TU-001 Tau NexGen Trial (NCT05269394).
  • Participants with pathogenic DIAD mutations, aged -10 to +10 years from expected symptom onset, with CDR scores 0-1.
  • Two cohorts: Symptomatic (CDR=0.5-1) and Asymptomatic (CDR=0), with staggered administration of lecanemab and etalanetug/placebo.

Main Results:

  • Primary objective: assess etalanetug vs. placebo in reducing tau spread (tau PET) from Week 24 to Week 104/208 in Cohort 1.
  • Secondary objectives: evaluate etalanetug vs. placebo on CDR-SB, CSF p-tau217/total-tau, cognitive, clinical, imaging, and fluid biomarkers.
  • Assessed amyloid reduction and safety of lecanemab monotherapy in Cohort 1.

Conclusions:

  • The trial will investigate the potential benefits of combining anti-tau etalanetug with lecanemab.
  • This combination therapy is being evaluated for its impact on tau pathology and disease progression in DIAD.