Phase 3 study to investigate the effects of BAN2401.

• Research type

  Research Study

• Full title

  AHEAD 3-45 Study: A Placebo-Controlled, Double-Blind, Parallel Treatment Arm, 216 Week Study to Evaluate Efficacy and Safety of Treatment With BAN2401 in Subjects With Preclinical Alzheimer’s Disease and Elevated Amyloid (A45 Trial) and in Subjects With Early Preclinical Alzheimer’s Disease and Intermediate Amyloid (A3 Trial)

• IRAS ID

  291949

• Contact name

  Stuart Ratcliffe

• Contact email

  stuartratcliffe@stpancrasclinical.com

• Sponsor organisation

  Eisai Ltd.

• Eudract number

  2020-004244-28

• Clinicaltrials.gov Identifier

  NCT04468659

• Clinicaltrials.gov Identifier

  IND 105081, IND number

• Duration of Study in the UK

  7 years, 0 months, 1 days

• Research summary

  Study BAN2401-G000-303 will be conducted as a public-private partnership with shared leadership responsibility across Eisai and the Alzheimer's Clinical Trials Consortium (ACTC), under a single protocol, consisting of 2 trials (the A45 Trial and the A3 Trial).

  The study is a 216-week treatment, multi-centre, randomised, double-blinded, placebo-controlled, parallel-treatment arm study in subjects with preclinical AD and elevated amyloid (A45 Trial) and subjects with early preclinical AD and intermediate amyloid beta (Aβ)(A3 Trial). At this time, there is no cure for preclinical AD or no way of slowing the underlying mechanism that eventually leads to the patient’s cognitive and functional deterioration.

  The A45 Trial and A3 Trial will have a shared Pre-randomization Phase and will have a
  common Schedule of Assessments within the Randomization Phase (with the exception of infusion interval. For both trials, the Pre-randomization Phase may last up to 90 days, and will consist of a Screening Period and a Baseline Period. Randomization Phase will consist of a 216 week Treatment Period and a 12 week Follow-up Period.

  Within each trial, subjects will be randomized in a blinded fashion to the BAN2401 or placebo arm with a 1:1 allocation. BAN2401 is a humanized IgG1 monoclonal antibody that binds to soluble Aß aggregates. BAN2401 is manufactured at Biogen RTP,under contract to Eisai.

  Approximately 1400 subjects will be randomized (1000 subjects in the A45 Trial, 400 subjects in the A3 Trial) at approximately 100 sites in the United Kingdom,Spain, Netherlands,USA, Japan, Singapore, Australia and Canada.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  20/SC/0450

• Date of REC Opinion

  16 Feb 2021

• REC opinion

  Further Information Favourable Opinion