On 22 May 2025, the Therapeutic Goods Administration (TGA) announced that the anti-amyloid monoclonal antibody donanemab (Eli Lilly, Kisunla) was approved in Australia for the treatment of Alzheimer’s disease (AD). This has been heralded by some as a breakthrough for the treatment of AD, reflecting a turning point from symptomatic treatments to disease-modifying therapies. Psychiatrists should understand this scientific context, as it underpins both the hope and the limits of what donanemab can achieve. The roll-out of disease-modifying treatment comes with significant challenges but also provides a unique opportunity to improve care for people with AD and other dementias.
RabinoviciGDSelkoeDJSchindlerSE, et al.Donanemab: Appropriate use recommendations. The Journal of Prevention of Alzheimer’s Disease2025; 12: 100150.
8.
SimsJRZimmerJAEvansCD, et al.Donanemab in early symptomatic alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA2023; 330: 512.
9.
BrockmannRNixonJLoveBL, et al.Impacts of FDA approval and Medicare restriction on antiamyloid therapies for Alzheimer’s disease: patient outcomes, healthcare costs, and drug development. Lancet Reg Health Am2023; 20: 100467.
10.
BuddHSAisenPSBarkhofF, et al.Two randomized phase 3 studies of aducanumab in early Alzheimer’s disease. The Journal of Prevention of Alzheimer’s Disease2022; 9: 197–210.
CaiLHuangJ. Schizophrenia and risk of dementia: a meta-analysis study. NDT2018; 14: 2047–2055.
13.
WangHSerap Monkul NeryEArdayfioP, et al.Modified titration of donanemab reduces ARIA risk and maintains amyloid reduction. Alzheimer's Dementia2025; 21: e70062.
14.
RentzDMAisenPSAtriA, et al.Benefits and risks of FDA-approved amyloid-targeting antibodies for treatment of early Alzheimer’s disease: navigating clinician-patient engagement. Alzheimer's Dementia2024; 20: 8162–8171.
15.
RossELWeinbergMSArnoldSE. Cost-effectiveness of aducanumab and donanemab for early Alzheimer disease in the US. JAMA Neurol2022; 79: 478–487.
16.
HtunHLTeshaleABRyanJ, et al.Social determinants of health and risk of dementia among older men and women: a 12-year cohort study in Australia. Alzheimer's Dementia2025; 21: e70065.
17.
BrodtmannADarbyDOboudiyatC, et al.Assessing preparedness for Alzheimer disease-modifying therapies in Australasian health care systems. Med J Aust2023; 218: 247–249.
18.
ReishNJJamshidiPStammB, et al.Multiple cerebral hemorrhages in a patient receiving Lecanemab and treated with t-PA for stroke. N Engl J Med2023; 388: 478–479.
NaismithSLMichaelianJCLowL-F, et al.Characterising Australian memory clinics: current practice and service needs informing national service guidelines. BMC Geriatr2022; 22: 578.
21.
LivingstonGHuntleyJLiuKY, et al.Dementia prevention, intervention, and care: 2024 report of the Lancet standing Commission. Lancet2024; 404: 572–628.
22.
UrsoDIntronaAGnoniV, et al.Donanemab eligibility in early Alzheimer’s disease: a real-world study. J Alzheim Dis2025; 105: 13872877251331243.
23.
EikelboomWSvan den BergESingletonEH, et al.Neuropsychiatric and cognitive symptoms across the Alzheimer disease clinical spectrum: cross-sectional and longitudinal associations. Neurology2021; 97: e1276–e1287.
24.
ConnorsMHSeeherKTeixeira-PintoA, et al.Dementia and caregiver burden: a three-year longitudinal study. Int J Geriat Psychiatry2020; 35: 250–258.
