The pharmaceutical company Eli Lilly, engaged in research against Alzheimer’s for years, she is ready to request soon the authorization of a new experimental drug against this disease. The donanemab slowed down significantly, by about 35%disease-related cognitive decline, and 40% the decline in the ability to carry out daily activities. The company announced the results of a placebo-controlled study of nearly 1,200 people – men and women – aged 60 to 85 with a confirmed diagnosis of Alzheimer’s disease. They all had symptomatic disease in an early stage, characterized by mild cognitive impairment and mild stage dementia.
I study
This is the Phase 3 TRAILBLAZER-ALZ 2 study, a randomized, placebo-controlled clinical trial. To evaluate the efficacy and safety of the drug, administered monthly intravenously, the researchers relied on the integrated Alzheimer’s disease rating scale (iADRS), a standardized test that measures the ability to perform daily activities. The drug was given to patients until the amyloid beta plaques cleared from their brains, which was monitored via brain scans.
The results of patients treated with donanemab were compared with those of participants in the placebo control group, highlighting the positive impact of the drug. Specifically, 12 months after the start of the trial, the 47% of patients treated with donanemab showed no disease progression versus 29% in the placebo group. At 18 months, a slowing of cognitive decline was observed in the donanemab group. 35% and a reduction in the ability to perform daily activities of less than 40% compared to the control group. A reduced risk of 39% of progression to the next stage of the disease.
In Alzheimer’s disease, two key proteins — tau and amyloid beta — build up in tangles and plaques, collectively known as clumps, which cause brain cells to die. Donanemab is an antibody similar to the one the body naturally produces to attack viruses, but specially designed to eliminate amyloid beta, as does lecanemab, another drug developed by Biogen and Eisai, which showed a 27% decline and was approved by the United States last January.
Eli Lilly researchers also evaluated the treatment in a subgroup of patients with high and intermediate levels of tau protein in the brain: these participants also found a slowing of cognitive decline between 22 and 29%.
A new hope against Alzheimer’s
Eli Lilly said it will quickly submit the results of the new study to the U.S. Food and Drug Administration and other global regulators. “We are delighted that donanemab has delivered positive clinical results with compelling statistical significance,” Daniel Skovronsky, scientific and medical director of Lilly, said in a statement. “This – he adds – First Phase 3 study of any investigational Alzheimer’s drug to deliver 35% slowing of clinical and functional decline“. These findings, according to Mark Mintun, vice president of the Eli Lilly research group, “suggest that people in the early stage of the disease may be the most responsive to amyloid-targeted therapies.”