T.The US Food and Drug Administration has not approved a new drug for the treatment of Alzheimer’s disease since 2003. To end this drought, Eli Lilly, an Indianapolis-based pharmaceutical company, developed a drug called donanemab, an antibody to clear deposits of amyloid-β peptides that form plaques in the brains of patients with AD. At the International Conference on Alzheimer’s and Parkinson’s Diseases, held virtually March 9-14, Lilly researchers announced the results of the Phase 2 study that donanemab slowed the progression of the disease. The study was launched on Saturday (March 13th) in the New England Journal of Medicine during the presentation of the team.
The study followed 257 patients with early stages of AD over a period of 76 weeks. The primary endpoint of the study was measured using scores on the Integrated Alzheimer’s Disease Rating Scale (iADRS). The assessment is based on two common systems for determining function in AD patients, namely, completing cognitive tasks such as looking up a list of words or naming objects, and performing daily activities such as dressing or dialing a phone.
The researchers report that the differences in iADRS scores between the placebo and experimental groups were evident at 36 weeks, and at the end of 76 weeks the decline was 32 percent lower in those taking the drug than those who did Placebo was given. Starting at 106 out of 141 points on the scale, those taking the drug still fell nearly seven points on the scale, while those given the placebo fell a little more than 10 points.
“From 18 months, these people went back six months more slowly compared to the people who didn’t get the drug,” says Maria Carrillo, the scientific director of the Alzheimer’s Association, who was not involved in the work CNN. “That’s another six months of better knowledge, better memories, better pleasant times with your family.”
“Donanemab has the potential to become a very important treatment for Alzheimer’s disease. We were pleased to see that not only was cognitive and functional decline slowed, but the amyloid plaques were also very much eliminated and the spread of tau pathology slowed, ”said Daniel Skovronsky, Lilly’s Chief Scientific Officer, in a press release . “The combination of clinical and biomarker results shows the potential for long-term modification of the disease.”
Although these secondary endpoints – clearance of amyloid plaques and slowing of tau pathology – improved in patients taking the drug, the changes were not statistically significantly different from the placebo group. As such, not everyone is convinced that the results of the primary endpoint will allow the drug to move forward. The colorful fool, An investment adviser website noted that the FDA did not review potential new drugs based on iADRS readings alone.