New drug a 'game-changer' for people with early stage Alzheimer's

Sharing data at the 2023 Alzheimer's Association International Conference in July, Eli Lilly and Company said the trial of donanemab brought hope "to people with Alzheimer's disease who urgently need new treatment options".

The Phase 3 Trailblazer-Alz 2 study showed donanemab "significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease".

Donanemab specifically targets deposited amyloid plaque and has been shown to lead to plaque clearance in treated patients.

The trial involved 1700 people (including 16 Australians) aged between 60 and 85, who all showed symptoms of early stage Alzheimer's.

Among all trial participants, it reduced amyloid plaque on average by 84 per cent at 18 months, compared with a 1 per cent decrease for participants on placebo.

Eli Lilly said participants were able to stop taking donanemab once they achieved a pre-defined criteria of amyloid plaque clearance (about half of participants met this threshold at 12 months, and about seven of every 10 reached it at 18 months).

"People living with early, symptomatic Alzheimer's disease are still working, enjoying trips, sharing quality time with family - they want to feel like themselves for longer," said Mark Mintun, group vice-president Neuroscience Research and Development at Lilly.

"The results of this study reinforce the importance of diagnosing and treating disease sooner than we do today."

Welcoming the results, Dementia Australia chief executive Maree McCabe said the news provides much-needed hope for people who are developing symptoms, have mild cognitive impairment or who are in the early stages of Alzheimer's disease.

"This research also highlights the importance of early diagnosis so people can access treatment and support as soon as possible," she said.

"We know the earlier people access support and services the better their health, care and lifestyle outcomes."

Australian Dementia Network Screening and Trials co-lead Professor Colin Masters described the results as a "game-changer". "We're all very excited about it," he said.

So is Dementia Australia dementia advocate Bill Yeates, who was diagnosed with younger-onset dementia in 2019.

"For me, it's that ray of hope that I believed would happen one day, where people living with dementia can have a future," he said. "One where you can lead a better life - one that you value."

Donanemab will need to be approved by the Therapeutic Goods Administration before it can be used in Australia.

"It also comes with possible side effects that need to be carefully monitored by health professionals," Ms McCabe said.

Those side effects can include temporary swelling in an area of the brain, or microhaemorrhages or superficial siderosis (a disorder caused by chronic slow or repeated bleeding into the subarachnoid space).

The trial results have been published in the Journal of the American Medical Association.

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