NE Journal of Medicine publishes promising study on the treatment of Alzheimer’s disease

The US Food and Drug Administration has not approved a new drug for Alzheimer’s disease since 2003, but a new study published by te New England Journal of Medicine on Saturday shows encouraging first results.

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

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

“We are confident in the results of the TRAILBLAZER-ALZ study,” said Daniel Skovronsky, scientific director of Lilly and president of Lilly Research Laboratories, in a declaration. “This is the first advanced stage Alzheimer’s disease study to achieve its primary endpoint 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 appeared to slow cognitive decline by about 32%.

Overall, about 40% of participants treated with donanemab achieved amyloid negativity as early as six months after starting treatment, and 68% achieved this goal after 18 months.

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

While the results are promising, the researchers said longer and larger trials are still needed to ensure the security of donanemab.

According to Centers for Disaster Control and PreventionAlzheimer’s disease is one of the 10 leading causes of death in the United States and the fifth leading cause of death among adults aged 65 or older.

The FDA is also under review of another, separate investigational drug of Biogen, a Cambridge-based and Japanese company partner Eisai Co.

Only a handful of drugs are approved to manage the symptoms of Alzheimer’s disease, and there aren’t any to treat the cause.