Alzheimer Scotland welcomes the launch of innovative treatment trial

AD-SMART: The Alzheimer’s disease Systematic Multi-arm Adaptive Randomised Trial

Alzheimer Scotland welcomes the launch of the AD SMART Trial which is an innovative trial that aims to test the effectiveness of several possible treatments for Alzheimer’s disease at the same time and reduce the time it takes to test treatments. Clinical trials typically focus on one medicine at a time and can take many years. By testing several medications simultaneously, potential new treatments could reach people faster.

This has led to advancements in the treatment of other health conditions, like motor neuron disease. The goal is to do the same for Alzheimer’s disease.

The trial is currently focussing on two medicines already approved and used safely for other health conditions: metformin, used to treat type 2 diabetes, and atomoxetine, used to treat ADHD.

Testing approved medicines further accelerates the speed of access for people with dementia, should they help treat the condition.

AD-SMART will regularly assess how well each medicine is working. Treatments that are not effective can be removed and replaced with new ones, making the trial potentially more efficient and cost-effective.

This exciting, UK-wide trial is led by the UK Dementia Research Institute and Alzheimer’s Research UK, with an Edinburgh site currently open at the Anne Rowling Regenerative Neurology Clinic. Further sites are expected to open across the UK.

Details on how to register interest in the trial can be found on the AD-SMART website.

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More Information:

The AD-SMART trial The Alzheimer’s disease Systematic Multi-arm Adaptive Randomised Trial (AD-SMART) is an innovative trial that aims to test the effectiveness of several possible treatments for Alzheimer’s disease at the same time.

This novel approach aims to reduce the time it takes to test treatments. Clinical trials typically focus on one medicine at a time, often taking ten years or more to determine effectiveness.

This means that potential new medicines can reach people faster, accelerating the development of life-changing treatments for dementia.

The UK Dementia Research Institute (UK DRI) and Alzheimer’s Research UK lead the trial in partnership with Health Data Research UK, supported by the Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR).

Which medicines are being tested?

The trial is currently focussing on two medications used for other health conditions, that have already been approved and are safe. Metformin, which is currently used for the treatment of type-2 diabetes, and Atomoxetine, currently used for the treatment of ADHD.

Alongside people with lived experience of Alzheimer’s disease, an international panel of experts selected these medicines for testing. This decision was based on previous evidence and lab-based research.

An aim of the AD-SMART trial is to test new medicines as they become available.

Design of the trial

The AD-SMART trial is referred to as a multi-arm, multi-stage platform trial, meaning:

1. Several medications are tested at the same time, with each medicine having its own group of participants.
2. Results are compared to a shared group of people who receive a “dummy” medication, otherwise known as a placebo group. This means that researchers can test the true effectiveness of the medicine.
3. Medication effectiveness is tested at frequent intervals. Medications that do not work are removed from the trial and are replaced with new ones.

This approach is potentially more efficient and cost effective than the standard clinical trial process.

Testing multiple medicines at once has led to advancements in the treatment of other health conditions, like motor neuron disease. The goal is to do the same for Alzheimer’s disease.

What it will involve

The trial will involve being randomly chosen to receive the treatment, or to receive the “dummy” placebo drug.

It will first involve in-person testing at the start of the trial, followed by testing six, 12 and 18 months after.

Tests will involve measures of cognition (e.g., memory and thinking) and activities of daily living (e.g., showering and cooking). Blood tests and brain scans will also be taken.

Who can get involved and where is the trial taking place?

The trial aims to involve people aged 55 and over with a diagnosis of Alzheimer’s disease or mixed dementia (Alzheimer’s disease and vascular dementia).

Up to 20 locations across the UK are expected to open over the next 12 to 18 months, to enable more people to get involved. Over 30 locations are planned in total. A location in Edinburgh is currently open for people to take part, based in The Anne Rowling Regenerative Neurology Clinic.

Importantly, not everyone with a diagnosis will be able to get involved. There is an assessment process that will determine eligibility.

Details on how to register interest in the trial can be found on the AD-SMART website.

Further information about the study can also be found on the Alzheimer’s Research UK website.