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A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease

Trial Profile

A Randomized, Double-Blinded, Placebo-Controlled Multiple Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BIIB037 in Subjects With Prodromal or Mild Alzheimer's Disease

Status: Discontinued
Phase of Trial: Phase I

Latest Information Update: 13 Nov 2019

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At a glance

  • Drugs Aducanumab (Primary)
  • Indications Alzheimer's disease
  • Focus Adverse reactions
  • Acronyms PRIME
  • Sponsors Biogen
  • Most Recent Events

    • 21 Mar 2019 According to a Biogen media release, based on a futility analysis of ENGAGE and EMERGE trials conducted by an independent data monitoring committee, the company has decided to stop the trials. The Independent data monitoring committee advise indicated that the trials were unlikely to meet their primary endpoint upon completion. The recommendation to stop the studies was not based on safety concerns.
    • 21 Mar 2019 According to a Biogen media release, as part of this decision, the EVOLVE study and the long-term extension of the PRIME study of aducanumab will also be discontinued.
    • 21 Mar 2019 Status changed from active, no longer recruiting to discontinued, as reported in a Biogen media release.
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