Posted: Mon 17th Jul 2023

New drug “a turning point in the fight against Alzheimer”

News and Info from Deeside, Flintshire, North Wales
This article is old - Published: Monday, Jul 17th, 2023

UK’s leading Alzheimer’s researchers have welcomed the results of a trial for the Alzheimer’s drug donanemab, developed by the pharmaceutical company Eli Lilly. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

Full results, confirming the initial findings announced in May, were presented today at the Alzheimer’s Association International Conference. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

According to the data published in the Journal of the American Medical Association, donanemab has shown to slow clinical decline by 35% in early Alzheimer’s patients with low or medium levels of tau, a brain protein. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

The drug, however, demonstrated no effect in people with high tau levels. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

“These results are another milestone,” said Dr Susan Kohlhaas, Alzheimer’s Research UK’s Executive Director of Research & Partnerships. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

She added that these findings hint at a changing outlook for dementia and its impact on people and society. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

Nearly 1,800 early-stage Alzheimer’s patients participated in Lilly’s trial known as TRAILBLAZER ALZ-2. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

Over 18 months, participants received a monthly infusion of either donanemab or a placebo. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

The treatment enabled patients to continue with day-to-day activities, including managing finances and taking medication. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

Despite the optimism, the study also highlighted the drug’s serious side effects, which could be life-threatening and require careful monitoring. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

Out of the patients treated with donanemab, 24% reported side effects, including brain swelling and infusion-related reactions. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

Tragically, four participants died during the trial, with their deaths suspected to be related to the drug’s side effects. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

“Regulators will need to balance these benefits and risks before it is given a license for use,” cautioned Dr Kohlhaas. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

In response to the drug’s promising results, Alzheimer’s Research UK has urged Eli Lilly to submit donanemab for UK regulatory review promptly. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

“We believe this review should be conducted by the UK regulators as a priority,” stated Dr Kohlhaas. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

She also stressed the need for collaborative dialogue among key stakeholders including the NHS, MHRA, NICE, the Association of British Neurologists, and the Royal College of Psychiatrists, to ensure prompt access to licensed treatments. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

Dr Kohlhaas also advocated for further investment in Alzheimer’s research for future generations. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

As the fight against Alzheimer’s intensifies, the UK is closely watching these trials, mindful of the challenges and opportunities they present in our collective quest to conquer this devastating disease. ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

The Alzheimer’s Society said: “Today’s full results support what we heard about donanemab in May – the drug is able to slow down the progression of Alzheimer’s disease by more than 20%.” ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

“This is truly a turning point in the fight against Alzheimer’s disease. ” ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

“We’re so proud that research we funded 30 years ago led to the breakthroughs we’re seeing today, and the research we’re funding now will be pivotal in unlocking more breakthroughs” ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

  ‌​‌‌​​​‌‍‌​‌​‌‌‌​‍‌​‌​‌‌​​‍‌​​‌‌‌‌​‍‌​​​​‌‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌‌​‌​‍‌​​​​‌‌​‍‌​‌‌‌‌‌​‍‌​​​‌‌​‌‍‌​​‌‌​‌​‍‌​‌​‌​‌‌‍‌​​‌​‌‌‌‍‌​​‌​‌‌​‍‌​​‌‌​‌​‍‌​​​‌​​‌‍‌​​‌‌​‌​‍‌​​​‌‌​​

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