Experts say the trial provides further evidence that attacking protein buildup in the brain can slow the progression of the disease.
An experimental drug for Alzheimer’s disease has been shown to significantly slow the cognitive and functional decline associated with the disease in results praised as “remarkable” by experts, despite some patients experiencing serious side effects.
US pharmaceutical giant Eli Lilly announced on Wednesday that in a late-stage study involving nearly 1,200 people in the early stages of Alzheimer’s disease, the drug, donanemab, slowed the progression of symptoms by 35 percent over an 18-year period. months compared to a placebo.
The effect was measured by the patient’s cognition and ability to perform daily tasks such as managing finances, driving, pursuing hobbies and talking about current events in a standardized index called the Integrated Alzheimer’s Disease Rating Scale (iADRS). ) is called.
Side effects included temporary swelling in parts of the brain, which occurred in nearly a quarter of the patients treated.
Lilly said the incidence of severe brain swelling in the study was 1.6 percent, including two deaths attributed to the condition, while a third may also have died from the treatment.
Nevertheless, the data was widely praised by independent experts, who said donanemab has the potential, if approved by regulatory authorities, to significantly improve the lives of people suffering from the most common form of dementia.
Lilly said she was “extremely pleased” with the study results and would submit the results to the US Food and Drug Administration (FDA) and other global regulators and hopes to gain US approval as early as the end of the year.
However, Mark Mintun, a top Lilly executive in neuroscience research and development, acknowledged that “like many effective treatments for debilitating and deadly diseases, there are risks associated with them that can be serious and life-threatening.”
According to the World Health Organization (WHO), more than 55 million people worldwide suffer from dementia, posing a major challenge to healthcare systems. With the aging of the population, the United Nations health organization expects the number of patients to rise to 78 million in 2030 and 139 million in 2050.
In January, the US approved lecanemab, an Alzheimer’s disease drug produced by Biogen and Eisai, which was found to slow the rate of cognitive decline by 27 percent and was also declared a game-changer by experts.
Alzheimer’s disease is characterized by a buildup of tau and amyloid beta proteins, which form plaques and tangles that cause brain cells to die and the brain to shrink.
Like lecanemab, donanemab is an antibody therapy that targets amyloid beta.
The patients in the late-stage study had intermediate levels of tau.
“This clinical trial is a real breakthrough, demonstrating a remarkable 35 percent slowing of cognitive decline in Alzheimer’s patients with high amyloid beta but low tau burden,” said Marc Busche, group leader of the UK Dementia Research Institute at University CollegeLondon.
Experts say treatments targeting both proteins may be even more successful.
Alzheimer’s disease accounts for as many as 80 percent of dementia cases, according to the Alzheimer’s Association. It gradually destroys thinking and memory and robs people of the ability to perform the simplest of tasks.
“This is the strongest phase 3 data for an Alzheimer’s treatment to date,” said Maria Carrillo, the chief science officer at the US Alzheimer’s Association. “This further underscores the inflection point we’re at for the Alzheimer’s field.”