The first new treatment for early symptomatic Alzheimer’s brings new hope to Australians in the initial stages of this insidious disease. Catherine Lewis reports.
The silent, stealthy stealing away of memory and self is the hallmark of Alzheimer’s disease, the most common form of dementia, impacting the thinking and behaviours of more than 433,000 Australians – a tally set to double by 2054.
Now the leading cause of death in NSW for the first time, and with 110% growth in those aged 85+ in the last two decades, its trajectory seems set. Dementia Australia warns that: “In the absence of a significant medical breakthrough, more than 6.4 million Australians will be diagnosed with dementia in the next 40 years, at a cost of more than $1 trillion.”
But hope is at hand. In May, the Therapeutic Goods Administration (TGA) green-lighted Eli Lilly’s Donanemab – brand name Kisunla – the first new drug to be approved in Australia for the treatment of early Alzheimer’s disease in 25 years, and the first that works to address the underlying cause.
Alzheimer’s – which results from genetic, environmental, and lifestyle factors – is characterised by pathological markers, including amyloid plaques, sticky clumps of protein that build up between nerve cells, blocking communication and eventually killing cells, leading to memory loss and confusion.
“Kisunla is not a cure for Alzheimer’s, but studies… show that it does slow the progress of dementia by several months.”
Professor Sue Kurrle, Northern Sydney Local Health District
Kisunla is administered each month via an intravenous infusion and works to target and clear amyloid plaques. While not a cure, Kisunla has proven in trials to reduce plaques by 84% and slow cognitive and functional decline by up to 35%, potentially extending quality-of-life and functional independence by several years.
“Kisunla is not a cure, but studies over 18 months show that it does slow the progress of dementia by several months when compared with a placebo drug,” says Sue Kurrle, clinical director, Northern Sydney Local Health District Rehabilitation and Aged Care Network. Professor Kurrle is also president of the Australian and New Zealand Society for Geriatric Medicine. “Kisunla is for the management of very early Alzheimer’s and does not have the same effect in people with moderate Alzheimer’s disease,” she warns.
Early detection is key. A University College London study found that people with dementia are diagnosed an average of 3.5 years after symptoms begin, or 4.1 years for those with early-onset – crucial time lost. Enter artificial intelligence (AI) natural language processing to dramatically speed up identification of the disease in Australian hospitals. “Many people (with dementia) are missing out on good care because we are not very good at identifying them or their needs,” says Velandai Srikanth, Peninsula Health’s National Centre for Healthy Ageing director and project lead.
Kisunla is the first new drug to be approved in Australia for the treatment of early Alzheimer’s disease in 25 years
“This new method offers a novel digital strategy for capturing and combining clues in written text, such as descriptions of confusion or forgetfulness, or alerts for distressed behaviour, to flag them for suitable care and support.
“Responsibly using AI in scientific research and dementia identification is potentially game-changing,” Professor Srikanth adds.
The Australian Dementia Network is hoping for similar success with its current trial of blood-based biomarker diagnostic tests. Linked to GPs across the country, these tests enable the timely and accurate diagnosis of Alzheimer’s by local doctors. The body is also pushing for investment in GP and specialist education, expansion of Memory Clinics and infusion centres and provision of patient support staff.
Timing is also crucial to Kisunla’s success. Initial eligibility for the drug is tipped to include just 10% to 20% of patients in Australia – those in the early symptomatic stages and with confirmed presence of amyloid plaque in the brain. They must also display a specific genetic profile, says Michael Woodward, head of dementia research and senior clinician, Memory Clinic at Melbourne’s Austin Health. “The presence of the APOE4 gene increases the risk of developing Alzheimer’s, but unfortunately, people with two copies of this gene – around 20% of people with Alzheimer’s – will be deemed ineligible (to take Kisunla), because they would be at higher risk of severe side effects, including brain bleeding and swelling,” Professor Woodward said.
Those with non-Alzheimer’s forms of cognitive impairment or dementia, not caused by amyloid, are also not eligible. But for those that are, Kisunla could be transformational. After 20 doses of the drug – around 18 months- worth of treatment – the vast majority of people ‘have no amyloid left’ in the brain, says Professor Woodward. “Which could add about 3.5 years of quality life to people who start on the treatment early enough.”
But quality costs. First up, scans to check for the presence of amyloid plaques can run to $1,000, while close ongoing supervision and MRI monitoring is needed while dosing. Kisunla is not on the pharmaceutical benefits scheme (PBS) and is around $4,700 per infusion, meaning an 18-month course tops $80,000. While Eli Lilly has applied for PBS funding and the Federal Government is being urged to fast-track access, the decision remains ‘in review.’
Almost $4 million-worth of funding from the Dementia Australia Research Foundation has enabled dementia- focused projects, including gene therapy, to explore if viruses can be used to deliver critical genes to boost the brain’s defences.
Locally, memory cafes, such as Rotary D-Caf at the Crows Nest Centre and Carers’ Group in Mosman are supporting patients and their carers, one flat white at a time.
Exercise is important to keep dementia at bay and assist with balance to prevent falls
Seaforth-based dementia-friendly choir, Sing for Joy, Hammond Care Social Clubs and Proveda’s Belong Club offer socialising galore – crucial as the World Health Organisation warns that social isolation can boost dementia risk by 50%. “We host regular dementia information sessions, helping people to stay empowered to live independently,” says Alison Hush, program officer at Belong Club. “Belong Club provides a welcoming and safe environment where people can connect. We also partner with local organisations like Dance Health Alliance to support people with conditions such as dementia and Parkinson’s, helping us offer inclusive opportunities for movement and connection.”
Community, compassion and scientific advancements provide a powerful trifecta for families living with Alzheimer’s and, while Kisunla is not a cure, it is a much needed shot of hope, and of progress. As Professor Woodward says: “We’ve been waiting a very long time to be able to offer patients a treatment of this nature.”
For support, contact the National Dementia Helpline on 1800 100 500.
