221AD205 Biogen - BIIB037 in Alzheimer’s Disease

• Research type

  Research Study

• Full title

  A Phase 2, Multicenter, Randomized, Parallel-Group, Double-Blind, Controlled Study of Aducanumab (BIIB037) in Subjects With Mild Cognitive Impairment due to Alzheimer’s Disease or With Mild Alzheimer’s Disease Dementia to Evaluate the Safety of Continued Dosing in Subjects with Asymptomatic Amyloid-Related Imaging Abnormalities

• IRAS ID

  255804

• Contact name

  Dakshaben Patel

• Contact email

  cta.submissions@biogen.com

• Sponsor organisation

  Biogen Idec Research Limited

• Eudract number

  2018-002102-31

• ISRCTN Number

  ISRCTN02477800

• Clinicaltrials.gov Identifier

  NCT02477800

• Duration of Study in the UK

  4 years, 9 months, 10 days

• Research summary

  Biogen is developing Aducanumab (BIIB037) a human anti-Aβ immunoglobulin (Ig) G1 monoclonal antibody (mAb) for the treatment of patients with AD or With Mild Alzheimer’s Disease Dementia. Previous studies using Aducanumab have shown that “amyloid-related imaging abnormalities” (ARIA) are the commonest side effect., and that the majority of these are asymptomatic (without symptoms). In the ongoing aducanumab studies (PRIME, ENGAGE & EMERGE), when an individual develops ARIA that is moderate or severe, dosing is suspended; however, results from the PRIME study so far have suggested that continuing dosing may be safe if asymptomatic.

  In the proposed study, the safety impact of continuing dosing in asymptomatic participants with ARIA is assessed in a 2-stage approach. In Stage 1 asymptomatic participants with mild to moderate severity ARIA on imaging will be dosed through; in Stage 2 asymptomatic participants with severe severity ARIA will be dosed through if the results for Stage 1pass the data safety monitoring committee recommendation after a review of the data.
  
  Participants will be required to undergo a series of assessments during the visits including PET and MRI scans, collection of blood samples, and completion of neuro-cognitive assessments to measure symptoms of Mild Cognitive Impairment (MCI) or AD and assess mood.
  The total duration of the study per participant will be up to 78 weeks, including a 60-day screening period, a 52-week treatment period, followed by an 18-week follow-up period.

  There will also be an extension study, which will look at how well-tolerated the study drug is over the long-term. The total duration of the study for each participant in the Long-Term Extension (LTE) will be up to 174 weeks; 29 additional planned visits after the main study has been completed.
  The study is sponsored by Biogen Idec Research Limited. Around 500 research participants in approximately 95 sites globally, will take part in this study.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  19/LO/0053

• Date of REC Opinion

  20 Mar 2019

• REC opinion

  Further Information Favourable Opinion