Breakthrough results in a Phase 3 trial for Eli Lilly’s Alzheimer’s drug treatment Donanemab have shown to significantly slow cognitive and functional decline in persons with mild Alzheimer’s disease (AD), the most common cause of dementia in Australia. This gives hope to millions of people living with the disease world-wide.
Results from the study showed that cognitive decline was slowed by 35% and functional decline by 40%, compared to placebo. After decades of Alzheimer’s research, the results confirm the benefits of removing the amyloid plaques found in persons with AD.
Leading dementia experts in the Australian Dementia Network (ADNeT) have welcomed the milestone findings. ADNeT Director, Professor Christopher Rowe, said, “This is another step forward and good news for persons with Alzheimer’s disease and those at high risk of developing it. The results are convincing and consistent with other trials. This drug should be available in the USA this year and hopefully in Australia soon after that.”
Donanemab was administered by a monthly antibody infusion which focussed on the removal of amyloid clumps, called ‘plaques’ – a defining hallmark of Alzheimer’s disease. The highly anticipated data shows statistically significant reductions of brain amyloid accumulation as early as 6 months after initiating treatment, with many patients reaching complete amyloid clearance. As the study primarily used participants with early symptoms of AD and mild cognitive impairment (MCI), it is evident that slowing of cognitive decline is greater when Donanemab is administered in the early stages of AD.
ADNeT researchers have been developing novel blood tests to detect AD, that could be used in primary care. With early detection and diagnosis of AD, the administration of Donanemab in future treatment interventions could produce even greater success in slowing cognitive decline. Professor Colin Masters, ADNeT Screening and Trials Co-Lead, said, “The Donanemab results together with the new blood-based biomarkers test are exciting breakthroughs in the field and have the potential to improve diagnosis and treatment outcomes for people living with this devastating disease.”
Lilly will seek approval from the United States Food and Drug Administration for Donanemab by the end of June. If approved, it will be the third amyloid-targeting Alzheimer’s drug to gain approval, joining similar drug Lecanemab, approved in January, on the market. ADNeT is currently recruiting participants to trial Lecanemab through the EISAI AHEAD 3-45 study. This trial will look at the benefits of removing amyloid before any symptoms of AD have developed.