AD-SMART
Alzheimer’s Disease Systematic Multi-Arm Adaptive Randomised Trial
A trial that tests multiple treatments at different times aiming to find one that can improve the symptoms of Alzheimer’s disease or slow down its progression in people with Alzheimer’s Disease.
What is this study about?
AD-SMART aims to speed up how better, safer treatments for Alzheimer’s disease are identified by using a multi-arm, multi-stage (MAMS) 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.
- Using planned checks to identify treatments that are not showing enough benefit, so they can be removed from the trial early.
- Allowing new treatments or new ways of measuring their effects to be added without needing to stop and restart the trial. This means that what would normally require several separate trials can be delivered on a single platform.
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).
The research team will also collect blood samples at the same time as these clinical tests 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 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.
The AD-SMART team is currently inviting proposals for digital outcome measures for the trial. Further information about the call and submission process is in the button below.
Call for Digital Outcome Measures Proposals
Type of study
Randomised trial
Contact details
Data Sharing
For any data sharing requests, please email the AD-SMART team at mrcctu.adsmart@ucl.ac.uk.
Who is funding the study?
AD-SMART is funded by the UK Dementia Research Institute, Alzheimer's Research UK, and the National Institute for Health and Care Research (NIHR).
When is it taking place?
The first two treatment arms of AD-SMART are due to run until 2031.
Where is it taking place?
Across 25 sites in the UK.
Who is included?
Adults aged 55 and over with symptomatic Alzheimer’s Disease (Mild Cognitive Impairment, Mild Dementia, Moderate Dementia)