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The study included 257 patients with early symptomatic Alzheimer’s disease; 131 received donanemab, while 126 received placebo. Researchers found that donanemab slowed the decline in cognition and daily function in patients with Alzheimer’s disease by 32% after 76 weeks, compared to those given a placebo.
Over an 18-month period, this 32% slowdown in decline could have a noticeable impact on patients with Alzheimer’s disease, noted Maria Carrillo, scientific director of the Alzheimer’s Association, who was not involved in the study.
“Over 18 months, compared to people who didn’t get the drug, these people declined six months more slowly,” Carrillo said. “That’s six more months of better cognition, better memories, better time with your family.”
The decline was measured using the Alzheimer’s Disease Integrated Rating Scale, which measures both cognitive and functional abilities, such as memory and the ability to perform daily tasks.
Carrillo said the results of the Phase 2 trial are early but promising and represent some of the strongest data on a single drug’s ability to slow the progression of Alzheimer’s disease.
“It has a lot of potential,” Carrillo added. “It could be a first step towards slowing or stopping cognitive decline in these early stages, which would be truly transformational for our field.”
The researchers also looked at the drug’s impact on the buildup of amyloid beta plaque and tau proteins, which are believed to be hallmarks of Alzheimer’s disease.
At 52 weeks, nearly 60% of the participants had achieved negative amyloid status, meaning their levels were at those of otherwise healthy people. At 76 weeks, amyloid plaque levels – measured in centiloids – fell 85 more centiloids than in those who received the placebo, the researchers reported.
Patients with these low levels of beta amyloid plaque were withdrawn from donanemab and received the placebo.
Slow down the disease
“Once these participants were cleared of the amyloid in the brain, the drug was removed and this slowing continued,” Carrillo said. “It’s important because you don’t have ongoing security monitoring or adverse events.”
Participants who received donanemab also showed a greater reduction in overall tau burden than those who received placebo.
Carrillo said this study was unique in that it screened participants for the presence of amyloid beta plaque and tau before entering the trial.
Some researchers in the field believe that “if you stop amyloid early enough and slow down this tau, you may be able to slow Alzheimer’s disease,” Carrillo. “This is what this newspaper is trying to show, and this is one of the very first times we see it.”
Research on donanemab is still early, and researchers say longer and larger trials are needed to determine the drug’s safety and effectiveness.
“We are extremely pleased with these positive results for donanemab as a potential therapy for people with Alzheimer’s disease, the only leading cause of death without treatment that slows disease progression,” Dr. Mark Mintun, vice -President of Pain and Neurodegeneration at Eli Lilly, said in a January statement announcing the trial results. Mintun said that further research underway will aim to replicate the results.
No new treatment approved since 2004
The US Food and Drug Administration has not approved a new drug for Alzheimer’s disease since 2004. The investigational drug for Alzheimer’s disease, aducanumab, developed by the pharmaceutical company Biogen and its Japanese partner Eisai, is currently under review by the FDA.
Many of the most promising drug candidates for Alzheimer’s disease aim to target amyloid beta plaques and tau proteins, as their accumulation correlates with the progression of Alzheimer’s disease. The goal with drugs such as donanemab is not to cure the disease, but to preserve a person’s memory and cognition for longer.
Alzheimer’s disease is the most common form of dementia and currently affects 6.2 million Americans aged 65 and older, according to the Alzheimer’s Association. According to the United States Centers for Disease Control and Prevention, that number is expected to reach at least 14 million people by 2060.
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