The Alzheimer’s Disease Systematic Multi-Arm Adaptive Randomised Trial (AD-SMART) aims to speed up how better, safer treatments for Alzheimer’s disease are identified by using a multi-arm, multi-stage (MAMS) clinical trial design. MAMS trials make it possible to test treatments more quickly and efficiently by testing multiple treatments at the same time in separate treatment groups and comparing them with a single placebo (dummy treatment) group alongside standard care.
A drug treatment will be considered successful in AD-SMART if, over 18 months, it is both safe and shows a meaningful difference to patients’ quality of life in one or more of the following measures:
- Cognitive symptoms (e.g., memory, problem solving)
- Ability to perform daily activities (e.g., showering, cooking)
- Neuropsychiatric symptoms (e.g., mood, anxiety, apathy).
In the first instance, the trial is testing whether either or both of two existing medicines (atomoxetine and immediate-release metformin) can relieve and improve symptoms in people with Alzheimer’s. Currently, they are used for other illnesses and are known to be safe and effective for those diseases. AD-SMART will also assess each treatment’s side effects (if any), whether they improve quality of life, and offer value for money to the health service.
The research team will also collect blood samples to learn how changes in levels of certain blood markers are linked to the progression and severity of Alzheimer’s. They will also conduct MRI brain scans at the start and end of the trial to look for changes in brain structure and function. This information will aid our understanding of how the treatments work to reduce symptoms and affect disease progression.
AD-SMART is led by the University College London Innovative Clinical Trials Unit.
