Race Against Dementia and the UK Focused Ultrasound Foundation, alongside teams at the University of Oxford and University College London, have launched a world-first clinical trial exploring the use of low-intensity focused ultrasound to improve cognitive function for people living with Lewy body dementia (LBD).
Estimated to account for over 15% of dementia cases, LBD is marked by progressive memory and attention impairment affecting thinking, movement, communication, and behavior. There is currently no cure for the disease and treatment options to help manage symptoms and slow progression remain very limited.
Now, in the first clinical trial of its kind, a UK-based research team is investigating the use of focused ultrasound – a rapidly evolving, noninvasive technology with 35 regulatory approvals worldwide – to improve the cognitive symptoms that gradually worsen for people living with LBD.
Rather than using drugs, low-intensity focused ultrasound harnesses sound waves to noninvasively stimulate the area of the brain linked with the production of a chemical messenger associated with LBD symptoms. The aim of the study is to increase production of this messenger, improving memory and attention. If successful, this method could offer an accessible treatment option, with rapid recovery times, to improve cognitive function in people with LBD and pave the way for similar trials for other neurodegenerative conditions.
The study, led by Ashwini Oswal, MD, and his team at the University of Oxford and experts at University College London, is the result of a partnership between Race Against Dementia and the UK Focused Ultrasound Foundation. It is funded through Race Against Dementia’s £4.2 million Teams programme, which backs disruptive ideas and novel approaches with grants of up to £750,000, and is delivered in partnership with medical research charity Rosetrees.
Researchers will enroll up to 30 participants to investigate if low-intensity focused ultrasound can stimulate the nucleus basalis of Meynert and increase acetylcholine signaling, potentially improving attention and memory. The team will test for target engagement with functional magnetic resonance imaging (fMRI) and magnetic resonance spectroscopy, allowing them to better understand the impact of low-intensity focused ultrasound on brain activity in patients.
The trial is currently recruiting. People with LBD based in the UK who are interested in learning more are advised to discuss with their doctor in the first instance. Consultants can find out more by contacting Dr. Oswal.
“Fast paced technology is the backbone of Formula 1, it drives performance, safety, and precision,” said Sir Jackie Stewart OBE, founder of Race Against Dementia. “Partnering with the UK Focused Ultrasound Foundation will enhance our endeavors to apply the same high-tech approach to dementia research and their focus on cutting-edge technology will allow for the acceleration of solutions.”
“I am delighted that our team has received this vital funding through a partnership between Race Against Dementia, the UK Focused Ultrasound Foundation, and the Rosetrees Trust,” said Dr. Oswal, MRC Clinician Scientist Fellow at the University of Oxford. “Our research aims to test whether a new, noninvasive way of stimulating the brain can improve symptoms and quality of life for people living with LBD. This is a devastating condition for which there is currently no effective treatment. If successful, our approach could lead to a new therapeutic option for LBD and may also inform the treatment of other forms of dementia.”
“We are proud to be supporting one of our UK-based Focused Ultrasound Foundation Centers of Excellence in tackling dementia – a condition that is on the rise in both the UK and worldwide,” said Philip Keevil, Chair of Trustees of the UK Focused Ultrasound Foundation. “The symptoms of dementia can have a significant impact on quality of life and the ability to function, which can be highly distressing, particularly for caregivers and family. This research represents a first step in alleviating that burden in those affected by LBD specifically, while creating hope in the field of neurodegenerative conditions more generally. We await the initial results with enthusiasm.”
How will this new approach fill current unmet needs in treatment for LBD?
Many symptoms of LBD are linked to the progressive loss of brain cells that produce acetylcholine, a chemical messenger that helps brain cells communicate and supports cognition. These cells sit in a small region called the nucleus basalis of Meynert. When these cells die, acetylcholine levels fall, contributing to cognitive problems.
Current treatments aim to boost acetylcholine by stopping its breakdown, but because they act throughout the body they can cause side effects. Moreover, existing studies on treatments for the disease typically require brain surgery to implant electrodes. What’s been missing is a way to directly and safely stimulate the nucleus basalis of Meynert without surgery and without debilitating side-effects.
This project will test a noninvasive alternative – low-intensity focused ultrasound – which uses sound waves to gently activate deep brain areas with accuracy, and has been shown to be safe, effective and precise in previous research relating to the brain. The study hopes to demonstrate that ultrasound stimulation can increase acetylcholine production, leading to improvements in memory and attention.
About Race Against Dementia
Race Against Dementia is a global charity founded by three‑time Formula 1® World Champion, Sir Jackie Stewart OBE, to speed up the pace of progress towards a world without dementia. With 152 million people projected to be affected by 2050, the charity funds pioneering research and empowers scientists to accelerate breakthroughs, bringing the speed, precision and teamwork of Formula 1 to dementia research. Since 2016, Race Against Dementia has funded more than £20 million, funded 65 researchers and backed more than 40 research projects across five continents.
About Focused Ultrasound
Focused ultrasound uses ultrasound energy guided by real-time imaging to treat tissue deep in the body without incisions or radiation. Worldwide, there are currently 180 clinical indications or disorders in various stages of development and 35 indications with regulatory approval. More than 1 million patients have been treated with focused ultrasound. In the UK, focused ultrasound is currently available (on the NHS) at specialist centres for the treatment of prostate cancer, uterine fibroids and essential tremor. It is also available privately for the treatment of Parkinson’s tremor.
About the UK Focused Ultrasound Foundation
Established in 2020, the non-profit UK Focused Ultrasound Foundation was created to improve lives by accelerating the development of this noninvasive technology. The UK Focused Ultrasound Foundation, along with its US counterpart, works to clear the path to global adoption by organising and funding research, fostering collaboration, and building awareness among patients and professionals.
About the Teams Programme
Race Against Dementia Teams Programme identifies high potential leaders – researchers with an inventive approach. Top scientists are supported to build a talented team of scientists. Awards of up to £750,000 are made to support the team for five years. Team selection is spearheaded by Rosetrees, a UK private medical charity. Race Against Dementia trains the entire team in a Formula 1-style mindset for focus and advancement.
About Rosetrees Trust
Rosetrees Trust, a UK private medical charity, has supported cutting-edge research for more than 30 years, funding over 2000 research projects. Their highly successful venture philanthropy approach, pioneered by Rosetrees chairman, Richard Ross, CBE, has generated more than £1 billion in follow-on funding from organisations such as the Medical Research Council, Wellcome and Cancer Research UK.
About Oxford University
Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the eighth year running, and number 3 in the QS World Rankings 2024. Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 300 new companies since 1988. The university is a catalyst for prosperity in Oxfordshire and the United Kingdom, contributing £15.7 billion to the UK economy in 2018/19, and supports more than 28,000 full-time jobs.