PRE-MASTODON-AD

PREliminary development of a Multi-Arm, multi-Stage Trial platfOrm for Dementia & mild cOgNitive impairment due to Alzheimer's Disease (PRE-MASTODON-AD)

Preparatory work for a multi-arm, multi-stage (MAMS) platform that will rapidly assess repurposed treatments for symptomatic Alzheimer’s disease.

What is this study about?

Our aim is to set up and implement a MAMS platform trial, MASTODON-AD, which in its first phase will evaluate three leading drugs with proof-of-concept evidence in Alzheimer's disease. The aim of this study is to carry out the initial preparatory work for this platform.

We will carry out a systematic drug selection process to identify the first three compounds to include in the platform. We will also finalise the set of outcome measures for the trial and complete trial design, including carrying out appropriate simulations. Each work package will be supported by dedicated PPIE (Patient and Public Involvement and Engagement).

 

Compound proposal

On behalf of the PRE-MASTODON-AD investigators, we are inviting proposals from the Alzheimer’s disease drug development community for compounds that can be repurposed for the treatment of symptomatic Alzheimer’s disease. Our aim is to gather available evidence for each proposed compound that can be presented to a panel of national and international experts who will then shortlist a maximum of 10 compounds on the basis of:

(i) potential efficacy and biological plausibility

(ii) safety

(iii) feasibility of testing in a platform trial.

Detailed evidence generation will then take place before selection of three lead compounds to be included in a multi-arm platform trial in the setting of the UK National Health Service. This drug prioritisation process and platform design are funded by a grant from the National Institute of Health and Care Research (UK) and supported by Alzheimer’s Research UK.

The deadline for proposal submissions is 18 August 2024 with the initial panel meeting due to take place in mid-September 2024. Please complete the proposal proforma and then send to mrcctu.mastodon@ucl.ac.uk.

Download the proposal proforma

 

The PRE-MASTODON-AD team consists of investigators from across the UK and is a partnership between the ACORD collaboration and Dementias Platform UK. The drug prioritisation process is being led by Professor Suzanne Reeves (UCL) and the panel will be chaired by Professor Gordon Wilcock (University of Oxford).

The study is being led by Professors Paresh Malhotra (Imperial College London), James Carpenter (MRC Trials Unit at UCL) and Vanessa Raymont (University of Oxford).

Confirmed Drug Prioritisation panel members include:

  • Prof Gordon Wilcock (Chair)
  • Prof Jeffrey Cummings
  • Prof Fiona Ducotterd
  • Dr Eric Karran
  • Prof John O'Brien
  • Prof Suzanne Reeves
  • Dr Alastair Reith
  • Prof Lon Schneider
  • Prof Rik Vandenberghe
  • Geri Barrett

Type of study

Randomised trial

Who is funding the study?

This trial is funded by the NIHR Efficacy and Mechanism Evaluation (EME) programme.

When is it taking place?

TBC

Where is it taking place?

PRE-MASTODON-AD will take place in the UK.

Who is included?

People with a diagnosis of Alzheimer's Disease and mild-to-moderate symptoms, including individuals with mild cognitive impairment and mild-to-moderate dementia.