Donanemab, developed by Lilly, is the first disease-modifying treatment for early-stage Alzheimer’s disease to be approved for use in Australia. The National Imaging Facility supported its development by providing MRI and PET imaging services to help generate critical evidence that contributed to its approval.
Dementia is a huge health burden for Australians. It is the second-leading cause of death in Australia, affecting nearly half a million Australians, and numbers are expected to double by 2058.
Alzheimer’s disease is the most common form of dementia, leading to progressive impairment of cognitive functioning and wellbeing.
Professor Michael Breakspear, Professor of Neuroscience and Psychiatry at the University of Newcastle and Director of NIF’s Hunter Medical Research Institute Node, describes Australia’s approval for new dementia drug donanemab as bringing dementia treatment into the modern era of molecular therapies, akin to the treatment of many other diseases, including infectious diseases and cancers.
Advanced PET and MRI imaging integral to clinical trials
NIF and its partner nodes have supported numerous industry-sponsored clinical trials, including those testing disease-modifying treatments for Alzheimer’s disease, through direct support and via the Australian Dementia Network (ADNeT).
The advanced PET and MRI imaging capacity provided by NIF has been critical for clinical trials such as those run by ADNeT – essential for establishing the effectiveness and safety of new treatments before they can be approved by Australia’s Therapeutic Goods Association – trials which Prof Breakspear has been supporting at Newcastle’s NIF Node.
“In the future, we aim to analyse the clinical data of the people receiving the treatment, to understand the mechanisms of its therapeutics effects, improve its safety and refine its clinical role,” says Prof Breakspear.
Ongoing imaging is crucial during treatment
Now donanemab has been approved, imaging is more important than ever to monitor disease progression and check for side effects.
Donanemab is a monoclonal antibody treatment and it works by targeting and removing neurologically damaging amyloid plaques in the brain.
Alzheimer’s disease is diagnosed with a PET scan or test of a patient’s cerebrospinal fluid for amyloid. Patients receiving donanemab will likely need another PET scan to see whether the amyloid has been cleared after treatment.
Imaging is a major part of future dementia treatment using monoclonal antibodies.
Prospective patients of donanemab also need to undergo an MRI scan to check the for the presence of severe vascular disease that can rule out this treatment.
During treatment, patients also need an MRI scan every two to three months to make sure they are not developing a serious side effect of the treatment – called amyloid-related imaging abnormalities.
Prof Breakspear is anticipating the benefits for Australian patients of NIF having nodes around Australia, providing widespread access to PET and MRI scanners.
The data from those scans will also improve patient outcomes in the long-term, by helping researchers develop better tools to detect very early Alzheimer’s disease and screen for those most likely to receive benefit, or least likely to experience side effects.
Treatment plus scans add up to more healthy years
ADNeT predicts that, to meet the expected demand for this treatment, the Australian health system will need to rapidly change with quicker and more effective diagnosis.
However, Prof Breakspear says the economic savings of accurately diagnosing and treating Alzheimer’s disease will easily outweigh the treatment costs in the longer term.
High-needs care required at the latter stages of dementia is often well beyond the capacity for a family. “Treatments that enhance functional wellbeing and independence save economically, as well as emotionally,” he says.
NIF continues to play an integral part in supporting research into dementia diagnosis and its management, and helping to develop novel therapies to improve quality of life and reduce the burden on Australians and the healthcare system.
Drug just the start of screening and treatment in Australia
Donanemab is only suitable for people in the early stages of dementia – however, that stage could last as long as 10 years.
The drug ‘clears out’ the amyloid that builds up during Alzheimer’s disease. It appears to be particularly effective if cleared before amyloid is accumulated and other pathological processes are set in motion.
If coupled with greater GP training, cognitive clinics and specialist services in Australia, Alzheimer’s disease could be routinely screened for and treated very early, like breast or bowel cancer.
“While these new therapies are not suitable for everyone, they are the first to address the underlying disease process in Alzheimer’s disease. The approval of donanemab will most likely herald other agents, along with combination therapies. It’s an important new era for the management of Alzheimer’s disease.”
This breakthrough treatment was also covered by mainstream media: ABC News, 9 News, News.com.au and Australian Seniors News.
Prof Breakspear also acknowledges the important contribution of Dr Jurgen Fripp and the CSIRO Australian e-Health Research Centre team, who have worked closely with NIF and the Professor on bioinformatics (warehousing, processing, mining data) for ADNeT.