The Australian Dementia Network (ADNeT) welcomes the decision by the Therapeutic Goods Administration (TGA) to approve the use of lecanemab in Australia.

Lecanemab is a disease modifying therapy proven to significantly slow the progression of Alzheimer’s disease, the second approved in Australia following the approval of donanemab in May 2025.

The TGA decision means Australians with a recent diagnosis of Alzheimer’s Disease have increased access to therapies proven to remove amyloid plaques from the brain, slowing the progression of the disease by one third. However, strict criteria on who should receive the treatment means many persons with dementia will not be eligible.

Speaking on the decision, ADNeT Director Professor Christopher Rowe MD FRACP believes this approval gives clinicians and their patients choice in which treatment best suits their circumstances and adds competition to the field that could lead to lower cost for this form of therapy.

“These treatments bring hope to people with a diagnosis of Alzheimer’s Disease and their families. They are the most substantial progress I have seen in decades of treating people with Alzheimer’s Disease and other forms of dementia. My hope is that the Federal Government can make these treatments accessible to all Australians, irrespective of where they live, their background or their income.”

Trials of lecanemab have shown the drug is most beneficial when administered early in the progression of Alzheimer’s Disease, emphasising the need for Australians with noticeable decline in thinking or memory to see their doctor sooner rather than later.

Professor Rowe continued, “For these new treatments to be most effective, we need patients to receive them as soon as possible. Blood tests for Alzheimer’s disease are becoming available that will aid earlier and more accurate diagnosis and triage appropriate patients to specialist assessment and treatment. We need to expand the current Australian trials of these blood tests to make it available to more GPs and specialists around Australia”.

Less invasive than existing diagnosis via PET scan or Cerebrospinal Fluid extraction, the plasma pTau217 blood test is currently being trialled by ADNeT at clinical primary care sites in Adelaide, Melbourne, and Newcastle and by the Florey Institute of Neuroscience at five specialist clinics in Victoria.

The ADNeT Clinical Quality Registry – which recently released its latest annual report – is playing a critical role in monitoring the safety and efficacy of the new disease-modifying therapies for Alzheimer’s Disease. The Registry collects data and supports best clinical practice on over 7,000 persons living with mild cognitive impairment or dementia in over 75 specialist sites around Australia.

The Registry is also working with specialists to monitor the short- and long-term benefits and side effects of amyloid monoclonal antibody treatment for AD. Areas of brain swelling and small brain bleeds are seen on MRI scan in 10% of those on these treatments but with the close monitoring required with this treatment, serious symptomatic adverse events only occur in about 0.5-1%.  

Professor Rowe also highlighted the need to prepare our health system for the new generation of tools and treatments for dementia.

“The three-year delay between first signs and getting a diagnosis of Alzheimer’s Disease and waiting times to see dementia specialists of over a year in many urban and rural areas of Australia are no longer acceptable. We need targeted investment to support early diagnosis and these new treatments to ensure best possible outcomes for patients.”

The latest Dementia in Australia report from the Australian Institute of Health and Welfare outlines how dementia is now the leading cause of death in Australia and by 2065 it predicts one million Australians will be living with the disease.

The growing demographic challenge of dementia emphasises the need for increased government support of dementia research into prevention, diagnosis and treatment to prevent or delay severe dementia.

Professor Rowe added,

“This is another landmark day for dementia treatment, but with increasing case numbers and ageing population, we need to unlock the next generation of treatments for all types of dementia. The drugs approved for Alzheimer’s Disease in Australia this year only exist because of government investment in discovery research and partnerships with industry to bring new treatments to patients. We need to build on this progress to date. Now is the time to invest more in medical research not less and invest especially in areas of highest future need like dementia prevention, diagnosis and treatment.”

Clinicians interested in participating in the ADNeT Clinical Quality Registry and individuals interested in registering their interest in participation in future clinical trials for dementia prevention and treatments can find more information on the ADNeT website.

Published 24 September 2025