Challenges associated with the development of “trial ready cohorts” for dementia prevention trials
BMJ 2025; 388 doi: https://doi.org/10.1136/bmj-2024-080275 (Published 07 January 2025) Cite this as: BMJ 2025;388:e080275
- Richard Milne, head of research and dialogue, deputy director1 2,
- Edo Richard, professor of neurology3 4,
- Carol Brayne, professor emeritus of public health medicine5
- 1Wellcome Connecting Science, Wellcome Sanger Institute, Hinxton, UK
- 2Kavli Centre for Ethics, Science, and the Public, University of Cambridge, UK
- 3Department of Neurology, Donders Institute for Brain, Cognition, and Behaviour, Radboud University Medical Centre, Nijmegen, Netherlands
- 4Department of Public and Occupational Health, Amsterdam University Medical Centre, Amsterdam, Netherlands
- 5Department of Psychiatry, Cambridge Public Health, University of Cambridge, UK
- Correspondence to: R Milne rm23{at}sanger.ac.uk
The UK government has committed to leading the world in clinical trials and to “transforming treatment for dementia.”1 This commitment continues implementation of O’Shaughnessy’s recommendations on commercial clinical trials in the UK.2 It includes establishing “clinical trial delivery accelerators”—multidisciplinary teams working to widen access to research, hasten recruitment, and embed trials in the UK medical research infrastructure. The first of these to be announced was the dementia trial accelerator.3 A core component of the dementia accelerator is the trial ready cohort, a pool of pre-screened potential trial participants. We argue that the potential of trial ready cohorts is unproven and suggest that their ability to contribute to dementia research relies on tackling the distinctive ethical challenges that they present.
Accelerating dementia trials
The dementia field has been the “graveyard of drug discovery.”4 Clinical trials in the field have had an almost 100% lack of success, involving nearly 200 000 participants and costing over $40bn.5 Despite recent US Food and Drug Administration approvals, the effectiveness and clinical value of the new drugs remain contested, as illustrated by the European Medicine Agency’s recent negative advice on lecanemab.67
Reasons for the lack of success include the focus on a small number of treatment targets8 and features of the clinical trial system such as poor study design and difficulty recruiting trial participants.9 The difficulty has been compounded as drug development has shifted from treatment towards preventing dementia among people at risk.10 This necessitates recruitment outside of clinical dementia populations and …
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