221AD304 - Phase 3b Study of Aducanumab in Early Alzheimer’s Disease

• Research type

  Research Study

• Full title

  Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (aducanumab) in Subjects with Alzheimer’s disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

• IRAS ID

  1003027

• Contact name

  Catherine Mummery

• Sponsor organisation

  Biogen Idec Research Ltd

• Eudract number

  2019-004368-22

• Clinicaltrials.gov Identifier

  NCT02477800

• Research summary

  The purpose of the study is to find out whether the study drug aducanumab has the
  potential to be a helpful treatment that slows down long-term disease progression in
  research participants with Alzheimer’s Disease (AD) who took part in previous clinical
  studies with this study drug (221AD103, 221AD301, 221AD302 and 221AD205).
  All participants will receive the study drug by an intravenous (IV) infusion every 4 weeks.
  The study drug target dose will be 10 mg/kg, after a slow increase in concentration of the
  study drug known as titration period as follows: 1mg/kg for the first 2 doses, 3mg/kg for
  the next 2 doses, 6 mg/kg for the next 2 doses, and 10mg/kg thereafter. Study duration for
  each research participant will be 126 weeks: approximately 8 weeks Screening Period,
  100 weeks Treatment Period and 18 weeks safety Follow-up visit after the last dose.
  This study is sponsored by Biogen. Around 2400 research participants in about 348 study
  centres globally, will take part in this study.
  In the UK, ethics approval was granted for 221AD301 and 221AD205; although only
  study 221AD301 recruited research participants.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  20/NW/0177

• Date of REC Opinion

  8 Jun 2020

• REC opinion

  Further Information Favourable Opinion