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Area of Science:

  • Neuroscience
  • Pharmacology
  • Clinical Trials

Background:

  • Alzheimer's disease (AD) treatment has unmet needs despite amyloid therapies.
  • Tau pathology correlates strongly with AD clinical impairment.
  • BIIB080, an antisense oligonucleotide, targets tau mRNA to reduce tau protein production.

Purpose of the Study:

  • Evaluate the efficacy, safety, and tolerability of BIIB080 in early AD.
  • Assess the dose-response of BIIB080 in reducing tau pathology.
  • Investigate BIIB080's impact on cognitive decline and AD biomarkers.

Main Methods:

  • Phase 2, randomized, double-blind, placebo-controlled study (CELIA, NCT05399888).
  • 416 participants with early AD (MCI or mild dementia), aged 50-80.
  • Intrathecal BIIB080 or placebo over 76 weeks; primary endpoint: CDR-SB change at week 76.

Main Results:

  • Enrollment for the Phase 2 CELIA study is complete.
  • Preliminary baseline characteristics are comparable to other early AD trials.
  • Full characterization of results will be presented.

Conclusions:

  • The ongoing CELIA trial will determine BIIB080's efficacy and safety versus placebo in early AD.
  • BIIB080 has shown promising effects on tau biomarkers in earlier studies.
  • This trial is critical for advancing tau-targeting therapies for Alzheimer's disease.