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Call for digital outcome measure proposals for the AD-SMART trial

 

The Alzheimer’s Disease Systematic Multi-Arm Adaptive Randomised Trial (AD-SMART) team are pleased to invite proposals for digital outcome measures.

AD-SMART is a UK-wide multi-arm, multi-stage (MAMS) platform trial for clinical Alzheimer's disease, with planned recruitment of 1200 participants across multiple centres nationwide. Participants are aged ≥55 years at the time of screening with a biomarker-confirmed diagnosis of Alzheimer’s disease or mixed dementia consisting of Alzheimer’s disease and Vascular Dementia. It represents a significant national effort to evaluate therapeutics for Alzheimer’s disease efficiently and rapidly and will begin with two repurposed agents, atomoxetine and metformin (selected by an international multidisciplinary panel after an open call for proposals). Funded by NIHR, the UK Dementia Trials Accelerator and ARUK, the trial is led by Professors Paresh Malhotra, Vanessa Raymont, and James Carpenter with input from multiple investigators and institutions across the UK.

Led by Professor David Llewellyn, this call is a unique opportunity for both the scientific community and industry to contribute validated, innovative, and patient-friendly digital tools that can strengthen the trial’s scientific outputs and be used as secondary outcome measures. The proposed digital outcome measures should complement the co-primary outcome measures of cognition (ADAS-Cog) and daily function (A-IADL-Q). They should not inadvertently influence co-primary outcome measures or compromise the integrity of the AD-SMART trial.

Please note that proposals that focus on early-stage unvalidated technologies, or those intended primarily to advance commercial product validation, will not be eligible. As this is a publicly funded trial, no financial compensation will be provided to proposers for provision of digital tool(s) to AD-SMART.

Submission Process:

Selection Process:

  • The proposals will be reviewed by the AD-SMART secondary digital outcome measures team and an expert panel.
  • Shortlisted proposers will be required to provide a lay demonstration to the Patient and Public Involvement and Engagement (PPIE) group, with the expectation that the digital tool is user-acceptability testing ready.
  • The highest-ranked proposals from the above processes will be invited to present to an expert panel, and the finalist(s) will be notified via email.

The AD-SMART team would like to thank all proposers in advance for their time, expertise, and commitment to this process. For further enquiries, please direct correspondence to mrcctu.adsmart@ucl.ac.uk.

Further information: