221AD305 - A Study to Verify the Clinical Benefit of Aducanumab in Participants with Early AD

• Research type

  Research Study

• Full title

  A Phase 3b/4 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Verify the Clinical Benefit of Aducanumab (BIIB037) in Participants with Alzheimer's Disease

• IRAS ID

  1005733

• Contact name

  Matthew Stagray

• Contact email

  cta.submissions@biogen.com

• Sponsor organisation

  Biogen Idec Research Limited

• Eudract number

  2022-001671-14

• Clinicaltrials.gov Identifier

  NCT05310071

• Research summary

  Summary of Research
  The purpose of this confirmatory study is to verify the clinical benefit of aducanumab (ADUHELM™, also known as BIIB037, the study drug) compared with placebo in participants with Alzheimer’s disease, including participants with either mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s disease.
  Participants will be assigned randomly in a 2:1 ratio to receive aducanumab or placebo by an intravenous (IV) infusion every 4 weeks, respectively. Treatment is initiated via titration, starting at 1 mg/kg and will escalate to 3, 6 and 10 mg/kg.
  The total duration of the study for each participant will be approximately 130 weeks, including a series of screening visits within 8 weeks before administration of the first dose, and a 104-week treatment period. Participants will additionally undergo a safety FU Visit 18 weeks after the final dose of aducanumab.
  This study is sponsored by Biogen. Approximately 1512 participants will be enrolled and randomised at about 220 sites globally

  Summary of Results
  : The lay language summary is located here:https://eur03.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.biogentrialtransparency.com%2Fen-us%2Fclinical-trial-results.html%3FnctId%3DNCT05310071&data=05%7C02%7Capprovals%40hra.nhs.uk%7Cad2a7571b69e4df1569c08dd40810ba6%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638737645203107741%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=1eXJFR5bwm6ySbVQCXiWuVRXcyMsDZnY4lqwBFgWYGA%3D&reserved=0

• REC name

  Scotland A: Adults with Incapacity only

• REC reference

  22/SS/0091

• Date of REC Opinion

  3 Feb 2023

• REC opinion

  Further Information Favourable Opinion