Alzheimer’s disease: drugmakers pull the plug on aducanumab phase 3 trials

  • Biogen

  • International Clinical Digest
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Takeaway

  • Biogen and Eisai are stopping the global phase 3 ENGAGE and EMERGE trials of aducanumab in early Alzheimer’s disease on grounds of futility.

Why this matters

Key results

  • ENGAGE trial and EMERGE trial are phase 3 randomized, double-blind, placebo-controlled trials assessing efficacy and safety of monthly aducanumab vs placebo among a planned 3210 total patients with mild Alzheimer’s disease dementia.
  • Main outcome for both is Clinical Dementia Rating–Sum of Boxes (CDR-SB) score.
  • Futility analysis conducted by an independent data monitoring committee indicated the trials were unlikely to meet their primary endpoint on completion.
  • Long-term extension of PRIME phase1b trial in prodromal or mild Alzheimer’s disease and EVOLVE phase 2 safety trial in mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia also being discontinued.
  • Biogen and Eisai are considering initiation of planned phase 3 trial of aducanumab for secondary prevention.