GN39763 - MTAU9937A in patients with Alzheimer's Disease

• Research type

  Research Study

• Full title

  A Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group, efficacy and safety study of MTAU9937A in patients with prodromal to mild Alzheimer’s disease

• IRAS ID

  234823

• Contact name

  Cath Mummery

• Contact email

  cath.mummery@uclh.nhs.uk

• Sponsor organisation

  Genentech Inc

• Eudract number

  2017-001800-31

• Clinicaltrials.gov Identifier

  NCT03289143

• Duration of Study in the UK

  4 years, 10 months, 20 days

• Research summary

  Approximately 360 participants will take part in this study at approximately 125 study centres located in North America, Europe, and Asia Pacific regions.

  The purpose of this study is to compare the effects, good or bad, of the study drug called MTAU9937A versus placebo (an inactive substance that looks like MTAU9937A) on participants and the Alzheimer’s disease to find out which is better.

  This Phase II, randomised, double-blind, placebo-controlled, parallel-group study will evaluate the effectiveness, safety and tolerability, and the way MTAU9937A is metabolised in the body in patients with prodromal Alzheimer's Disease (pAD) to mild Alzheimer's Disease (mAD).

  The study treatment is defined as the study drug plus the radiolabelled substance used during PET imaging procedures used to determine levels of tau and amyloid pathological proteins in the brain ([18F] Genentech tau probe 1 [GTP1] for tau and the amyloid radiolabelled substance for amyloid.
  
  Patients will be randomly assigned to one of three active, IV dose arms (1500 mg, 4500 mg, or 8100 mg MTAU9937A) or to an IV placebo dose arm in a 2:3:2:3 (1500 mg:4500 mg: 8100 mg:placebo) ratio. All patients participating in the open label extension (OLE) will receive MTAU9937A 4500 mg IV.

  The study consists of a screening period where a potential participant goes through a series of assessments to see whether they are eligible to enter the trial, a double-blind treatment period where the participant is given either the active drug or placebo, an optional open-label extension (OLE) period where the participant is given the opportunity to continue in the study knowing they will be given the active drug, and a safety follow-up period.

• REC name

  London - Central Research Ethics Committee

• REC reference

  18/LO/0476

• Date of REC Opinion

  10 Apr 2018

• REC opinion

  Unfavourable Opinion