Ad-Smart Adaptive Trial Aims to Speed Alzheimer’s Drug Development

The UK Dementia Research Institute and Alzheimer’s Research UK have begun the Alzheimer’s disease Systematic Multi-arm Adaptive Randomised Trial (Ad-Smart). The trial will evaluate several repurposed medicines simultaneously, starting with the ADHD drug atomoxetine and the diabetes drug metformin, before adding further candidates. Recruitment started at Cambridgeshire and Peterborough NHS Foundation Trust and Surrey and Borders Partnership NHS Foundation Trust, with sites at Imperial College London, Edinburgh and Southampton. Up to 20 NHS sites are expected to open over the next 18 months, enrolling more than 1,000 participants.

The Independent

Alzheimer’s affects roughly 600,000 people in the UK, and existing trial designs can take a decade to determine a drug’s efficacy. Ad-Smart adopts an adaptive platform model used in oncology, allowing ineffective arms to be dropped quickly and new treatments to be introduced without restarting a full trial. Researchers say this could halve the time needed to assess potential therapies and bring effective options to patients faster.

The Independent

Prime Minister Andy Burnham, whose father died of dementia in September, said he is proud to back the initiative and wants Britain to lead breakthroughs that change lives. Chief investigator Professor Paresh Malhotra stressed that traditional “one drug, one trial” approaches are too slow and that the adaptive design lets researchers compare multiple mechanisms of neurodegeneration. The government reported that its target to speed up clinical trials has been met, with average set-up time for commercial trials falling by 35 % to 100 days in the three months to March this year, down from 153 days a year earlier.

The Independent

• Estimated UK Alzheimer’s prevalence: ~600,000 people.

The Independent

• Planned enrolment: >1,000 participants across up to 20 NHS sites.

The Independent

• First drug-arm conclusions expected by 2030, with participants undergoing regular scans and blood tests.

The Independent

• Commercial trial set-up time reduced by 35 % (100 days vs. 153 days).

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• “Then we can start testing something else. That’s the best way to get effective treatments to patients as quickly as we can.” — Prof Malhotra, chief investigator professor

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• “That means more treatments tested more quickly, and for people living with Alzheimer’s, that could make all the difference.” — Dr Sheona Scales, director of research at Alzheimer’s Research UK

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• “People can lead a brain healthy lifestyle, get involved in research studies, and support research through working with dementia charities and encouraging governments to fund research.” — Elsewhere

The Independent