UK Launches Trial Testing Diabetes and ADHD Drugs for Alzheimer's Treatment

A new clinical trial has begun in the United Kingdom, employing a novel approach that scientists believe could significantly shorten the timeline for discovering effective Alzheimer's treatments. The AD-SMART study will simultaneously test multiple drugs, beginning with two medications already in use for type 2 diabetes and attention deficit hyperactivity disorder (ADHD).

The trial's primary objective is to assess whether these repurposed drugs can alleviate Alzheimer's symptoms, such as memory loss and cognitive decline, and help patients maintain their quality of life.

Angela Bucksey, 67, who was diagnosed with Alzheimer's in January, is the first participant to receive treatment in the AD-SMART trial. "We have Alzheimer's in the family," Bucksey stated, sharing that her mother and aunts also had the condition. "My mother had it and my aunts, so it was a disappointment rather than a shock when I was diagnosed because I knew it would restrict my life. But I was determined that it wasn't going to define me."

She expressed feeling empowered by her participation, noting, "Instead of just sitting there, you're standing up and saying, I will fight back."

Alzheimer's disease is the most prevalent form of dementia, affecting approximately 600,000 individuals in the UK. Prime Minister Andy Burnham, whose father recently passed away from Alzheimer's, acknowledged the profound impact of dementia on families. "That's why I'm proud to see this trial being launched in the UK, so that cutting-edge treatments can reach patients here as soon as possible," he said.

The AD-SMART study utilizes a multi-arm, multi-stage platform trial design. This method allows for the simultaneous testing of several treatments, with results compared against a placebo group. Participants in this type of trial have a greater chance of receiving an active medication compared to traditional studies.

Crucially, if a drug demonstrates a lack of benefit, it can be quickly removed from the trial and replaced with a new candidate treatment. This adaptive strategy has been successfully implemented in trials for cancer and motor neurone disease.

The two initial drugs under investigation are metformin, commonly prescribed for type 2 diabetes, and atomoxetine, used to treat ADHD. These were selected by an international panel of experts. Professor Paresh Malhotra, chief investigator for the study and a group leader at the UK Dementia Research Institute Centre for Care Research & Technology at Imperial College London, explained that both drugs may help reduce brain inflammation, a key factor in neurodegeneration.

"For too long, Alzheimer's research has moved at the pace of one drug, one trial, one answer - sometimes taking a decade or more before we know if we've found something that works," Professor Malhotra stated. "We are applying advances from cancer and other conditions to accelerate testing of treatments for people with Alzheimer's disease."

For the trial drugs to be considered successful, they must show a positive impact on participants' cognitive abilities and their capacity to perform daily activities. "That's what patients and their carers care about," Professor Malhotra added.

Approximately 1,200 individuals with mild to moderate Alzheimer's will be recruited for the study across more than 30 sites in the UK, including locations in Cambridgeshire, Surrey, London, Southampton, and Edinburgh. Researchers anticipate completing the evaluation of the initial drugs by 2030, with the potential to introduce additional treatments during this period.

Participants will undergo regular health assessments, including cognitive tests, to monitor the effectiveness of the treatments. Angela Bucksey's husband, Steve, who is serving as her study partner, shared that joining the trial has provided a sense of hope. "People who know we are on a drug trial understand that we're doing something about it and, rather than be sorry for us, they can be encouraging."

Dr. Sheona Scales, director of research at Alzheimer's Research UK, emphasized the urgency of developing new treatment options. "Time is precious" for individuals living with Alzheimer's disease.

Individuals diagnosed with Alzheimer's who are interested in participating can register their interest on the AD-SMART website. The trial is a collaborative effort led by the UK Dementia Research Institute and Alzheimer's Research UK, with support from partners including the National Institute for Health and Care Research, the Medical Research Council, and Health Data Research UK. Funding for the trial is provided by the UK government.