A new drug may be available soon to effectively slow the cognitive decline of people with Alzheimer’s.
Eli Lilly and Company reported Wednesday that their experimental drug donanemab proved safe and effective in its phase 3 clinical trial.
Lilly is moving forward with global regulatory submissions based on’s positive results in the hopes of bringing the Donanemab product to market as quickly as possible.
The company intends to submit its drug approval application to the Food and Drug Administration within the next few months.
Dr. Leah Croll is a clinical neurology assistant professor at the Lewis Katz School of Medicine of Temple University and a neurologist at Temple University Hospital. She says that this is a fascinating time for those affected by Alzheimer’s.
“The Alzheimer’s drug pipeline has met disappointment after disappointment for many years. I am hopeful that we’re now entering a different era.” Croll told Healthline that any development could be significant.
Donanemab significantly slows cognitive decline.
Donanemab, which was tested on over 1,100 people with early-symptomatic Alzheimer’s, slowed cognitive decline and functional decline by 35 percent compared to placebo.
According to an instrument that measures the severity of the disease, 47% of those taking the drug did not experience any cognitive decline, compared to only 29% of those who were given a placebo.
The drug users also showed a 40% reduction in decline compared to those taking the placebo. They were better able to do everyday activities such as driving, talking about current affairs, or hobbies.
Participants who took donanemab were 39% less likely to progress to the next phase of the disease.
Dr. Brendan Kelley is a neurologist at UT Southwestern’s O’Donnell Brain Institute specializing in dementia. He says that although the study was relatively small, its implications are enormous.
Speaking to Healthline, Kelley said that the study affected people who were treated early in their disease course. This will have implications for improving our screening and accuracy for early diagnosis of Alzheimer’s disease.
The drug reduced abnormal plaques in the brain.
Donanemab removes abnormal accumulations of a protein known as amyloid in the brains of people with Alzheimer’s.
In Alzheimer’s disease, the amyloid protein accumulates and forms plaque.
Plaque can cause inflammation and block brain synapses.
As Alzheimer’s progresses, the plaques can spread to other brain parts.
Researchers measured the amyloid levels in participants’ brains to understand the impact of the drug on amyloid buildup. They found that 34% achieved clearance within six months and 71% at 12 months.
The drug is designed to reduce the amount of amyloid that has already accumulated in many of the patients who participated in the study.
Researchers also assessed how tau levels, another protein in Alzheimer’s patient’s brains, affected drug effectiveness.
Donanemab was more effective for people with lower tau levels, even though people with higher tau levels still benefitted.
Croll says the information “is consistent with prior research showing us that this class is best for those in early stages of Alzheimer’s disease.”
Potential side effects
Although the rate of severe anomalies was low, some safety concerns should be considered.
Most participants reported swelling and bleeding. Some also experienced headaches and confusion.
Brain swelling and bleeding were observed in 31,4% of the participants who took donanemab.
Croll stated that although most patients don’t experience any symptoms from these side effects, they are still significant, and we need to weigh the risks associated with this drug carefully.
Kelley says it is essential to create a strategy for monitoring these side effects and addressing any that might occur.
Kelley says the study found a link between a person’s APOE genotype – a genetic factorTrustedSource for Alzheimer’s disease – and their risk of experiencing these side effects.
Kelley stated, “This may be an important issue to discuss with the patient if this drug is being considered.”
Kelley says that more research is needed to determine whether the slowing of the heart continues past the 18-month mark and for how long the person should take the medication.
He added that it’s essential to monitor the long-term usage of the drug so that doctors can evaluate risks and benefits and better understand safety profiles.
Kelley explained that this is a new treatment area. “There are multiple factors to consider, including when to use the medication, how to advise patients on expectations and risks, and how to monitor safety,” she said.