RecruitingPhase IIIInterventional

A flexible initiative to test therapies for Alzheimer’s disease

The AD-SMART study is a four-year project designed to find new treatments for Alzheimer’s disease. It will test two existing medicines, atomoxetine and metformin, which are already used safely for other conditions. Researchers want to see if these drugs can improve memory, thinking skills, and daily activities for people with Alzheimer’s. The study will also check for any side effects and if the medicines improve quality of life. Participants will be compared to those receiving standard care or a dummy treatment. If successful, these medicines could become new options for people living with Alzheimer's, improving their well-being and daily lives.

At a glance

Status

Recruiting

Phase

Phase III

Sponsor

University College London

Enrolment target

1,200

Start

01 May 2026

Estimated completion

30 Sep 2029

Medical condition: Symptomatic Alzheimer’s Disease (Mild Cognitive Impairment, Mild Dementia, Moderate Dementia) Medical condition in lay language: Alzheimer’s disease (AD) Therapeutic areas: Diseases [C] - Nervous System Diseases [C10]

What is this study about?

The AD-SMART study is looking for new ways to help people with Alzheimer's disease. While there's lots of research happening, finding effective treatments remains a big challenge. This study is designed to be a faster and more efficient way to test potential new medicines. It will run for about four years and focus on two existing medicines: atomoxetine and metformin.

These two medicines are already approved and safely used for other health conditions. Researchers want to find out if they could also help people with Alzheimer's. Specifically, they'll be checking if these drugs can ease symptoms, improve memory and problem-solving, and help with daily activities like showering or cooking. The study will also carefully look at any side effects and whether the treatments improve a person's overall quality of life. The goal is to see if these medicines could offer real value to people with Alzheimer's and the healthcare system.

To decide which medicines to test, an international panel of experts, alongside input from patients and the public, carefully reviewed many options. This study is a "Phase III" trial, which means it's a big step towards potentially making these medicines available for people with Alzheimer's if they prove to be safe and effective. If a treatment is successful, it will then be reviewed by health authorities to ensure it meets strict safety and quality standards before it can be used more widely.

Key takeaways

Exploring if existing medicines (atomoxetine, metformin) can treat Alzheimer's.
A four-year study aiming for quicker, more efficient treatment discovery.
Will assess memory, daily activities, quality of life, and safety.
Involves regular assessments, blood tests, and MRI scans over 18 months.
Information gained will help future Alzheimer's patients, even if you don't feel direct benefits.

Who may be eligible?

This study is looking for adults aged 55 or older who have been diagnosed with Alzheimer’s disease or a mix of Alzheimer’s and vascular dementia. You'll need to have had a recent test that confirms signs of Alzheimer's in your blood, spinal fluid, or brain scans.

There are also some important health checks. You'll need to have healthy liver function and, if you're a woman who could become pregnant, a negative pregnancy test. You must also be able to undergo an MRI scan, though some specific medical conditions (like certain pacemakers or metal implants) might mean an MRI isn't safe for you. If you can't have an MRI for these reasons, you might still be able to join the study.

Finally, you and a close friend, family member, or carer (called a 'study partner') must be willing to give your informed consent to take part. You also need to be able to stick to the study schedule, including starting the trial treatment within two weeks of being assigned to a group.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 55 years old or older?
Do you have a diagnosis of Alzheimer's disease or mixed Alzheimer's/vascular dementia?
Have you had recent tests confirming signs of Alzheimer's?
Can you have MRI scans safely (or are you medically unable, but still potentially eligible)?
Are you able to attend appointments and take study medication as planned?
Do you have a friend, family member, or carer willing to be your 'study partner'?

Answer every question to see your result.

What does participation involve?

If you join the AD-SMART study, you'll be assigned to one of three groups: one will receive standard care plus atomoxetine, another standard care plus metformin, and a third will receive standard care plus a dummy treatment (placebo). You won't know which group you're in, and neither will the study team. Both you and your study partner will need to complete questionnaires and assessments at each visit to help the researchers understand how you're doing. Some of these visits will be in person at the study site, especially at the beginning, at 6, 12, and 18 months, and at the end of the study. Other visits might happen over the phone or by video call.

Before starting, you'll have blood tests and an ECG (a simple heart check) for safety. You'll also have blood samples taken at the start, at 6, 12, and 18 months, which will help researchers understand how the disease progresses. MRI scans of your brain will be done at the start and end of the study to look for changes. During the first four weeks, there will be weekly phone calls as the medication dose is slowly increased. The study treatment typically starts within two weeks of joining. The study is expected to run from January 2026 to March 2031, but your personal participation would involve regular check-ups over 18 months.

Potential risks and benefits

While participating, you might not directly feel better from the treatments, as this is precisely what the study is trying to find out. However, the information gained will be hugely important for improving care for future patients with Alzheimer's disease. Taking part might also lead to other health issues being discovered by the study team, who would then inform your GP. Possible risks include discomfort from answering questionnaires, slight pain or bruising from blood tests, or rare skin irritation from ECG patches. While MRI scans are generally safe, some people find them uncomfortable due to lying still or claustrophobia. The study drugs have known safety profiles from their use in other conditions, but you might experience different or new side effects. You are always free to leave the study at any time.

Locations (1)

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Approximate
-, England

Common questions

What is Alzheimer's disease?

Alzheimer's disease is a condition that affects the brain, causing problems with memory, thinking, and behaviour over time.

What are atomoxetine and metformin?

These are two medicines already used for different health conditions. Researchers are now testing if they can also help people with Alzheimer's.

Will I know which treatment I'm getting?

No, this is a 'blinded' study, meaning neither you nor the study team will know if you're receiving atomoxetine, metformin, or the dummy treatment (placebo).

How long will my participation last?

If you join, your participation will involve regular checks and treatments over 18 months to see how you respond.

What happens if a treatment works?

If a treatment is successful, it will undergo strict review by health authorities (like the MHRA) and health service advisors (like NICE) to make it available on the NHS.

How to find out more

Shabinah Ali

mrcctu.adsmart@ucl.ac.uk +44 (0)207 670 4700 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.