The drug, donanemab, has been shown to significantly slow cognitive decline in people with early symptoms of Alzheimer’s by 35 per cent compared to the placebo.
Participants who were administered donanemab also had 40 per cent less decline in their ability to perform activities of daily living at 18 months and a further 39 per cent lower risk of progressing to the next stage of the disease.
The trial involved 1,734 participants and full results will be presented at the Alzheimer’s Association International Conference in July and submitted for publication in a peer-reviewed clinical journal.
However, the new drug does come with risks. Two trial participants died as a result of dangerous swelling in the brain, and a third died after experiencing swelling.
The brain swelling cited as a cause of death for the two participants was an adverse side-effect from donanemab treatment, although only 1.6 per cent of the participants experienced severe swelling.
Despite this, the success rate is something of a breakthrough, and is unlikely to be a hurdle for Food and Drug Administration approval in the United States, given that a similar treatment, lecanemab, was approved in January of this year.
“We are encouraged by the potential clinical benefits that donanemab may provide, although like many effective treatments for debilitating and fatal diseases, there are associated risks that may be serious and life-threatening,” Mark Mintun, M.D., group vice president of Neuroscience Research & Development at Lilly, and president of Avid Radiopharmaceuticals said.
Director of the Australia Dementia Network at the University of Melbourne, Professor Christopher Rowe, acknowledges the risks associated with the new drug but emphasises that they are to be expected given the nature of the treatment.
Professor Rowe also notes that donanemab has the added benefit of less frequent dosing and seems to be more effective than lecanemab in removing amyloid, which progressively builds up and is responsible for cognitive decline in Alzheimer’s disease.
Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories, commented on the success of the trial, “Over the last 20 years, Lilly scientists have blazed new trails in the fight against Alzheimer’s disease.
We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer’s disease in this trial.”