NE Journal of Medicine launches promising study on Alzheimer’s treatment

The Food and Drug Administration has not approved a new Alzheimer’s drug since 2003, but a new study published by Tthe New England Journal of Medicine in Saturday is showing promising initial results.

Donanemab, an antibody treatment produced by the pharmaceutical company Eli Lilly and Company, targets a modified form of amyloid-β (Aβ) peptide – a plaque that accumulates in people’s brains with Alzheimer’s. Early-stage clinical trial results showed that at around 52 weeks, the levels of amyloid plaque in those who received the experimental drug reached a negative status. In other words, his amyloid plaque levels were the same as those of the average person.

To prepare for the study, half of the 275 participating patients received the drug for 76 weeks as part of the study, while the other half received a placebo. Those involved were people with early symptomatic Alzheimer’s disease.

“We are confident in the results of the TRAILBLAZER-ALZ study,” said Daniel Skovronsky, Lilly’s scientific director and president of Lilly Research Laboratories, in a demonstration. “This is the first study in the final stage of Alzheimer’s disease to reach its primary outcome in the primary analysis. Donanemab has the potential to become a very important treatment for Alzheimer’s disease. “

By monitoring memory and the ability to perform daily tasks, the researchers also found that the drug appears to slow cognitive decline by about 32%.

Overall, about 40% of donanemab-treated participants reached amyloid negativity six months after starting treatment, and 68% reached that goal 18 months later.

“We are pleased to see not only a slowdown in cognitive and functional decline, but also a very substantial clearance of amyloid plaques and a slowdown in the spread of tau pathology,” said Skovronsky. “The constellation of clinical results and biomarkers indicates the potential for long-term modification of the disease. We are grateful to the patients, caregivers and researchers who participated in this remarkable study. “

Although the results are promising, the researchers said that longer and more expansive trials are still needed to ensure donanemab security.

According Centers for Disease Control and Prevention, Alzheimer’s is one of the top 10 causes of death in the United States and the fifth leading cause of death among adults aged 65 and over.

The FDA is also currently undergoing a review by another, separate experimental drug from Biogen, the Cambridge-based and Japanese company partner Eisai Co.

Only a few drugs are approved to control Alzheimer’s symptoms, and there are none to treat the cause.