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Is A New Alzheimer’s Drug On The Way?

Clinical trial findings indicate that the following therapy with a possible breakthrough experimental drug, approximately a ranking of 7/10 Alzheimer’s patients, were free of the disease’s signature brain plaques.

Is A New Alzheimer’s Drug On The Way?

According to results reported in the New England Journal of Medicine on March 13, the drug donanemab greatly slowed the brains of the patients. A total of 257 patients took part in the second half clinical trial, with around half of them receiving infusion donanemab four times a year for up to a year and a half. Half of the participants were given a placebo.

Is A New Alzheimer's Drug On The Way?

“The treatment was highly effective at reducing amyloid from the brain,” Apostolova said. “By the conclusion of the study, 70% of people who had elevated levels of amyloid were basically in the amyloid-negative zone, which is very profound.” Such a proportion hasn’t been identified for other treatments that have successfully eliminated amyloid in the past, so that’s pretty impressive.”

The aggregation of the second type of protein known as tau, which forms “tangles” inside the brain tissue of Alzheimer’s patients, is a hallmark characteristic of the disorder. Tau seems to be a key player in Alzheimer’s disease, according to experts. Donanemab does not have a target or treat the tangles of proteins that are a symptom of late-stage Alzheimer’s disease, but researchers expect that by scrubbing the brain of amyloid-beta, they can also avoid tau aggregation, said.

Donanemab performed so well in this experiment that the majority of patients were weaned off it before the study started, according to Apostolova.

“More than half of the patients were willing to avoid medication because it went too well,” she said. “It was no longer appropriate to give it because they were amyloid negative.” “Wow, that’s a big deal.” According to Apostolova, the medication tended to delay the development of Alzheimer’s disease in brain exercise studies. “Those who took the medication had a 32 percent higher score than those who didn’t,” she said. “Both groups dropped, but the donanemab party dropped 32% less, which was huge.” 

While not any of the brain exercise findings were statistically important, they all indicated a slowing of development of 20% to 40%, according to Apostolova.  According to Maria Carrillo, the Alzheimer’s Association’s chief scientific officer, “these exciting new data inspire us.” And “These observations are promising because they are the first positive outcomes on a key outcome indicator linked to memory and thought in a phase 2 Alzheimer’s study”. Carrillo went on to say that “much testing needs to be performed on this new drug treatment,” citing the need for bigger studies to validate donanemab’s benefits.

When donanemab enters phase 3 clinical trials, some side effects will need to be considered. The results of these tests will decide if the medication is approved by the US Food and Drug Administration. The treatment works by attracting and dissolving advanced amyloid plaques. The amyloid-beta proteins that are loose in the brain are then extracted from the brain via blood vessels.

“Once the amyloid protein is extracted from the brain through blood vessels, it must travel via the blood-brain barrier, which may result in a leakage,” Apostolova explained. According to Apostolova, over a quarter of clinical-trial patients experienced brain swelling due to micro-hemorrhages in tiny blood vessels. Six percent of people had complications as a result of this side effect. Headaches, changes in mental state, confusion, vomiting, nausea, and trouble walking are also possible symptoms.

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