RecruitingPHASE3INTERVENTIONAL

An Evaluation of Treatments for Sustained Clinical Response (18 Months) in Symptomatic Alzheimer's Disease

This important study, called AD-SMART, is carefully looking at new ways to treat Alzheimer's disease in people aged 55 and older. It's comparing two potential new medications, atomoxetine and metformin, against a dummy pill (placebo) to see if they can help improve memory, thinking, and a person's ability to do daily tasks over an 18-month period. Researchers will also check how these treatments affect quality of life and carer burden. The study is designed to find out quickly if a treatment is working or not, so that effective treatments can reach patients sooner. Participants will be representative of people with Alzheimer's disease in the UK.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

University College, London

Enrolment target

1,200

Start

24 Jul 2026

Estimated completion

01 Mar 2031

Alzheimer's Disease (AD)Mild Cognitive Impairment Due to Alzheimer's Disease Alzheimer Disease Dementia

What is this study about?

This study, called AD-SMART, is a really important research project looking into new treatments for Alzheimer's disease. As you might know, Alzheimer's affects memory, thinking, and daily life. This study wants to find out if two medicines, called atomoxetine and metformin, can help people with Alzheimer's disease to feel better and improve their daily living over 18 months. These medicines are being compared to a 'placebo', which is a dummy pill that looks just like the real medicine but contains no active drug. This helps researchers understand if any improvements are truly due to the new treatments.

The study involves people aged 55 and over who have been diagnosed with Alzheimer's disease. By comparing the real medicines to a placebo, and also looking at things like quality of life and the impact on carers, the researchers hope to identify effective new treatments. The study is designed to be very efficient, meaning it can quickly determine if a treatment is showing promise or if it's not working as expected, so that valuable time isn't wasted.

The main goal is to see if these treatments can improve how well people think and remember things, and how they manage their everyday activities. They'll also be tracking other important aspects like mood, how people feel about their quality of life, and the support needed by their carers. This comprehensive approach ensures that if a treatment is found to be effective, it will be truly beneficial for people living with Alzheimer's disease in the UK.

Key takeaways

Tests new treatments (atomoxetine and metformin) for Alzheimer's disease.
Compares active drugs to a dummy pill (placebo) over 18 months.
Aimed at improving memory, thinking, and daily activities.
Involves people aged 55+ with confirmed Alzheimer's disease.
Includes regular health checks, MRI scans, and blood tests.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be at least 55 years old, with no upper age limit. You must have a confirmed diagnosis of Alzheimer's disease, or a mixed type of dementia which includes Alzheimer's. Researchers will also check your scores on certain memory and thinking tests.

An important part of joining is that blood tests or special scans (like a PET scan or CSF test) must have recently shown signs of Alzheimer's in your body. This helps make sure that the study is testing treatments on the right people. You also need to be able to have regular MRI scans during the study, so if you have certain metal implants or severe claustrophobia, you might not be able to take part.

Before joining, you'll also need to be willing and able to follow the study schedule, including taking the study medication and attending appointments. For women who could become pregnant, a negative pregnancy test is required. Checks on your liver function will also be done to ensure it's healthy enough for you to participate safely.

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 dementia including Alzheimer's?
Have you had recent tests (like blood tests or special scans) that showed signs of Alzheimer's?
Can you have MRI scans (no pacemakers, certain metal implants, or severe claustrophobia)?
Are you able and willing to attend regular study appointments and take medication as instructed?
Are your liver function tests within the normal range?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned by chance (like flipping a coin) to receive either one of the two new medicines being tested, or a dummy pill (placebo). Neither you nor the study team will know which you are receiving – this is called 'double blinding' and helps keep the results unbiased. You'll take the study medication regularly.

The study lasts for 18 months, during which you will have several visits to the study clinic. These visits will involve various tests to check your memory, thinking skills, and your ability to do daily activities. You'll also be asked questions about your mood, quality of life, and any symptoms you might be experiencing. Your study partner (a close family member or friend) will also be asked questions about these things at your appointments.

Throughout the study, you'll need to have regular blood tests and MRI scans. These help the researchers monitor your health, how the treatment might be working, and to ensure your safety. All these assessments help the researchers understand how the treatments are affecting you over time. You'll also be followed up to track your health after the main treatment period.

Potential risks and benefits

Participating in this study might offer some potential benefits; for example, you would receive careful monitoring by a medical team and could potentially receive a new treatment that might improve your Alzheimer's symptoms. However, there's also a chance you might receive a placebo and therefore not directly benefit from the investigational drugs. As with any medication, there could be side effects from the study drugs, some of which might be unknown. The study team will monitor you closely for any issues, and you'll be provided with detailed information about known side effects before you decide to join. It is important to remember that participating in a clinical trial is always voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Windsor Research Unit
Verified postcode
Cambridge, United Kingdom· Recruiting
Two Bridges Research & Development Clinic
Verified postcode
Chertsey, United Kingdom· Recruiting

Common questions

What is Alzheimer's disease?

Alzheimer's disease is a common type of dementia that causes problems with memory, thinking, and behaviour. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere with daily tasks.

What is a placebo?

A placebo is a 'dummy' pill or treatment that looks exactly like the real medication but doesn't contain any active drug. It helps researchers understand if the real medicine is truly causing any changes by comparing it to no active treatment.

How long does the study last?

The main treatment period for this study is 18 months, during which you will have regular appointments and assessments. There will also be some follow-up after the main treatment ends.

Will I know if I'm getting a real drug or a placebo?

No, neither you nor your doctor will know whether you are receiving one of the study drugs or the placebo. This 'blinding' helps ensure the study results are as fair and accurate as possible.

What are the new medicines being tested?

The study is testing two different medications, atomoxetine and metformin, to see if they can help improve symptoms in people with Alzheimer’s disease.

How to find out more

Trial Management Team UCL InCTU

mrcctu.adsmart@ucl.ac.uk +44 (0)20 7670 4700 Official trial record

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