New Drug Donanemab Slows Cognitive and Functional Decline in Alzheimer's Disease
Key Highlights :
The world is on the brink of a major breakthrough in the fight against Alzheimer’s disease, as a new drug has been found to slow cognitive and functional decline. Donanemab, made by Eli Lilly and Company, has been shown to slow decline by 35-36% in a late-stage phase 3 clinical trial. Almost half (47%) of those on donanemab had no clinical progression of disease at one year compared to 29% on placebo, a study showed.
The drug also resulted in 40% less decline in the ability to perform activities of daily living, according to the firm. Furthermore, participants on donanemab experienced a 39% lower risk of progressing to the next stage of disease compared to placebo, according to Eli Lilly. This is the first phase 3 trial of any investigational medicine for Alzheimer’s disease to deliver 35% slowing of clinical and functional decline.
Dr Richard Oakley, associate director of research at the Alzheimer’s Society in the UK, said: “After 20 years with no new Alzheimer’s drugs, we now have two potential new drugs in just 12 months – and for the first time, drugs that seem to slow the progression of disease. This could be the beginning of the end of Alzheimer’s disease.”
Dr Susan Kolhaas, executive director of research and partnerships at Alzheimer’s Research UK, said: “This is incredibly encouraging, and another hugely significant moment for dementia research. This is hugely exciting news as it provides further evidence that it is possible to slow down Alzheimer’s disease.”
Brain swelling, a known side effect of drugs of this type, occurred in 24% of the participants, with 6.1% experiencing symptoms. Bleeding occurred in 31.4% of the donanemab group and 13.6% of the placebo group. Most cases of swelling or bleeds were “mild to moderate” and responded to treatment.
Dr Charles Marshall, honorary consultant neurologist at , said: “When the full results are published as a paper we will be able to start carefully balancing the risks and benefits, and this will inform decisions about whether donanemab should be routinely given to patients with Alzheimer’s disease.”
John Hardy, professor of neuroscience and group leader at the UK Dementia Research Institute, , said: “It is great news to have a success with a second anti-amyloid drug. This should dispel any lingering doubts about this approach. Having two drugs is great for competition.”
Dr Tom Russ, director of the Alzheimer Scotland Dementia Research Centre, said: “The results of the donanemab trial are very welcome and will bring many people with dementia and their families some much-needed hope. While this is another encouraging development, the UK NHS is not ready to implement an infusion-based therapy such as donanemab or lecanemab, should they become licensed treatments in the UK.”
It is clear that the world is on the cusp of a first generation of treatments for Alzheimer’s disease, and the news of donanemab is incredibly encouraging. It provides further evidence that it is possible to slow down Alzheimer’s disease, and with two potential new drugs in just 12 months, we could be on the brink of the end of Alzheimer’s disease. However, there are risks of serious side effects that need to be fully scrutinised before donanemab can be marketed and used, and there needs to be substantial new investment in dementia clinics that can deliver accurate diagnosis, treatments that are given as infusions, and appropriate safety monitoring. With this, we should be really encouraged by this news, which is yet more proof that research can take us ever closer towards a cure.
