In 2025, two anti-amyloid monoclonal antibody medications, donanemab (Kisunla) and lecanemab (Leqembi) were approved by Australia’s Therapeutic Goods Administration (TGA). This was considered a breakthrough for treatment of mild/early Alzheimer’s dementia. These medications reduce amyloid plaques in the brain, thought to contribute to dementia, in the TRAILBLAZER-ALZ 2 trial. Those who were taking donanemab had greater improvement in a measure of cognitive and functional impairment, compared to those who did not.
These medications are not without controversy. While these medications are Therapeutic Goods Administration (TGA) approved (that is, they have been assessed to be beneficial and safe), they have not been approved in the Pharmaceuticals Benefit Scheme (PBS) and people need to pay out of pocket, with some estimates of around $40,000 – 50,000 per year. To be eligible for these medications and demonstrate the presence of Alzheimer’s disease, specific scans are required; amyloid PET scans or cerebrospinal fluid analysis – both potentially costly and difficult to access. The major side effects of these medications are oedema, or swelling of the brain and bleeds within the brain. These side effects are called amyloid-related imaging abnormalities (ARIA), and mean that people taking the treatment are recommended to have regular brain scans (MRIs) 3 – 4 times in the first six months of treatment. These medications are administered intravenously, fortnightly or every 4 weeks and need to occur in specialist treatment centres, of which there are few in Australia, and mostly located in metropolitan regions. It has been estimated that overall, the cost of this treatment might be between $80,000 – $100,000 per year.
The challenges in accessing such a treatment for some populations emphasise inequities in the healthcare system. For example, people need to be diagnosed “early”, when people in rural locations, those who identify as culturally and linguistically diverse and may have other comorbidities are unable to access diagnosis. The significant cost and requirements to travel, ability to tolerate brain scans, notwithstanding that there are many other types of dementia, not just Alzheimer’s type which also require treatments. Preventative measures and how to “live well” with dementia still need to be important targets of research and health policy. It is thought that only 5-10% of people living with dementia will realistically be able to access these medications.
In spite of these disparities, the biggest issue is whether these medications reducing amyloid plaques translate into “real world benefit”. The recently published Cochrane review (April 2026) covered 17 studies and concluded that there was minimal clinical benefit in terms of improvements in memory, thinking and functioning, with significant risks of side effects of ARIA. However, there have been criticisms of this review, in that most of the studies included involved previous anti-amyloid therapies which did not remove amyloid nor achieve any clinical improvements, with only two studies which used the now approved medications. This risks ‘diluting’ clinical effects. In addition, the different study designs and outcomes measures making it difficult to synthesise and pool the results. Another criticism is how to interpret the “slowing” or “improving” of cognitive and functional decline – which is very individual for each person living with dementia and their families.
New medications are exciting developments and for many offer hope, but currently they come with significant concerns. There are many things that you can do to help slow progression of cognitive impairment, stay healthy and independent. The Forward with Dementia website is packed with information and ideas to live a healthier, happier quality of life!
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