Alzheimer’s Research UK says new Donanemab drug means ‘we’re entering new era where disease could become treatable’
“We’re entering a new era where Alzheimer’s disease could become treatable,” said Alzheimer’s Research UK, after results of a trial examining the new drug Donanemab were published.
Hailed as a “turning point in the fight” against the disease, it was found to slow “clinical decline” by up to 35 per cent, which meant that Alzheimer’s patients could still perform day-to-day tasks including shopping, housekeeping, managing finances and taking medication.
The drug, manufactured by Eli Lilly and Company, requires approval in the UK from the medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).
Health spending watchdog NICE is already assessing whether it could be used in the NHS, should it receive MHRA approval.
The drug works by removing the amyloid protein that builds up in the brains of people with Alzheimer’s.
Researchers examined almost 1,800 people with early-stage Alzheimer’s, giving half a monthly infusion of donanemab and the other half a placebo, over 18 months.
After 76 weeks of treatment, donanemab was able to slow clinical decline by 35.1 per cent in people with early Alzheimer’s whose brain scans showed low or medium levels of another protein that builds up in Alzheimer’s patients called tau. When the results were combined for people who had different levels of this protein, there was a 22.3 per cent slowing in disease progression.
Eli Lilly said treatment with donanemab reduced amyloid plaque on average by 84 per cent at 18 months, compared with a one per cent decrease for participants on placebo.
The disease stalled for a year in 47 per cent of people taking the drug who had early-stage disease and low or medium levels of tau.
In a small number of people there were serious side effects, such as brain swelling. Three deaths in the donanemab group and one in the placebo group were considered “treatment related”.
After the final results on the safety and efficacy of the drug were published, Dr Susan Kohlhaas, executive director of research and partnerships at Granta Park-based Alzheimer’s Research UK, said: “Today’s announcement marks another milestone. Thanks to decades of research, the outlook for dementia and its impact on people and society is finally changing, and we’re entering a new era where Alzheimer’s disease could become treatable.
“As a potential first-generation treatment, donanemab’s effects are modest. But these results provide further confirmation that removing amyloid from the brain can change the course of Alzheimer’s, and may help people affected by this devastating disease if they’re treated at the right time.”
Sir John Hardy, professor of neuroscience and group leader at the UK Dementia Research Institute, UCL, added: “The successful outcome of the Eli Lilly’s anti-amyloid antibody donanemab is great news for Alzheimer’s disease and confirms the positive and similar outcome for Eisai’s lecanemab trial late last year.
“The results are very similar, and that in itself is reassuring.