A new drug has shown progress in hampering the effects of Alzheimer’s Disease.
Eli Lilly and Co. announced in May that its new experimental drug has made advances in slowing the progression of Alzheimer’s Disease. Researchers noted the most profound results within the phase 3 trial for this new drug, known as donanemab.
Alzheimer’s disease is a brain disorder known for the progressive degeneration of memory and thinking in those afflicted. The National Institute on Aging says the disease is the seventh leading cause of death in the U.S. and the most common cause of dementia.
Health experts say that over 6 million Americans aged 65 and older may be afflicted with the disease.
The FDA recently fast-tracked the approval of another drug, Leqembi, to treat this disease, as previously reported by The Dallas Express.
This new trial, known as TRAILBLAZER-ALZ 2, was a “randomized, double-blind, placebo-controlled study” and evaluated 1,182 participants who were in the early stages of the disease and had displayed mild impairment. These patients were divided by their levels of brain protein tau, a protein that researchers say is a biomarker for the progression of the disease.
Researchers observed that patients given the drug demonstrated 35% less cognitive decline, 40% less decline in their ability to perform daily activities, and a 39% lower chance of progressing to the next stage of the disease compared to the population that had taken the placebo.
This is compared to only a 27% decrease in reduced mental abilities for the drug Leqembi.
In addition, 47% of these patients demonstrated no decline on the Clinical Dementia Rating Scale (CDR-SB).
“We are extremely pleased that donanemab yielded positive clinical results with compelling statistical significance for people with Alzheimer’s disease in this trial,” said Daniel Skovronsky, chief scientific and medical officer of Lilly and president of Lilly Research Laboratories, according to a press release.
“This is the first Phase 3 trial of any investigational medicine for Alzheimer’s disease to deliver 35% slowing of clinical and functional decline,” he continued.
However, despite the promise demonstrated, the drug also presents a significant level of risk.
Scientists recorded that brain swelling was a side effect associated with the new drug, appearing in 24% of patients, with just over 6% demonstrating symptoms.
Rates of brain bleeding also more than doubled between the two groups, with the medicated group demonstrating a rate of just over 31% compared to the placebo rate of just under 14%.
Researchers said the rate of serious brain swelling in the drug study was 1.6%. Three patients died as a result of brain swelling.
The group vice president of Neuroscience Research & Development at Lilly, Mark Mintun, acknowledged the risks posed by the new drug but said he was “encouraged” by its potential to effect a positive change.
“We note that these results suggest that people in the early pathological stage of [the] disease could be the most responsive to therapeutics targeting amyloid,” said Mintun in the press release, referring to the amyloid plaque believed to be responsible for Alzheimer’s.
“We thank the participants in the clinical trial and their loved ones for their time and commitment to finding solutions for this disease,” he continued.
Lilly officials plan to file for approval in the United States by the end of June, according to Reuters. Officials expect a final decision to be reached by the end of this year or early 2024.
Obesity — a major health issue associated with numerous diseases — is a known risk factor for Alzheimer’s. A recent study found that obesity was linked to 21 genes related to Alzheimer’s disease.
