Trials for a new Alzheimer’s treatment have suggested that the groundbreaking drug works better in patients enduring the earlier stages of the disease and those under the age of 75.
Eli Lilly’s new drug, donanemab, aims to slow down the progressive degeneration of memory and thinking in patients with Alzheimer’s by clearing amyloid plaques from their brains, as previously reported in The Dallas Express.
Although the company’s request for accelerated FDA approval of donanemab was rejected for insufficient evidence at the start of 2023, the first Phase 3 trial run on 1,182 participants yielded promising results.
Compared to the control group, test subjects receiving the drug reported 35% less cognitive decline, 40% less decline in their ability to perform daily activities, and a 39% lower chance of progressing to the next stage of the disease.
Another clinical trial on 1,736 participants similarly reported a significant slowing of the disease’s progression, according to findings published on July 17 in the online journal JAMA.
Although scientists do not know what drives cognitive decline, lifestyle factors — such as being obese and eating highly processed foods — appear to increase one’s likelihood of developing them, as previously covered by The Dallas Express.
Still, scientists noted an important difference in how well donanemab worked: the patient’s stage of Alzheimer’s and age.
While the drug cannot reverse or repair the brain damage already inflicted by Alzheimer’s disease, it attacks the amyloid protein tau that accumulates as plaque in the brain. Those in the earlier stages of Alzheimer’s (or even in a pre-Alzheimer’s stage of mild cognitive impairment) and under the age of 75 tended to have less brain plaque and responded best to the drug, according to The New York Times.
“The earlier you can get in there, the more you can impact it before they’ve already declined and they’re on this fast slope,” said Dr. Daniel Skovronsky, Eli Lilly’s chief medical and scientific officer, NYT reported.
Another noteworthy aspect of the donanemab study was that when patients discontinued the drug once their amyloid levels fell below a specific threshold, the effects appeared to be long-lasting. Eli Lilly scientists estimated that it would take almost four years for amyloid levels to increase above the threshold again.
Despite yielding groundbreaking results, amyloid plaque-clearing drugs like donanemab and Biogen and Eisai’s lecanemab — marketed as Leqembi after gaining FDA approval — carry certain risks.
Both drugs have been shown to present some safety concerns, mainly brain swelling and bleeding. Three people died in each of the trials conducted on donanemab and lecanemab, according to NYT.
Yet some Alzheimer’s patients are willing to take the risk if it means slowing their cognitive decline.
Jim Sirois, 67, began experiencing cognitive decline about four years ago and has participated in a donanemab trial.
While Jim and his wife Sue remain uncertain about the drug’s effectiveness, they have not noticed any significant increase in his symptoms.
It is estimated that 6.7 million Americans over the age of 65 are living with Alzheimer’s, and the number is projected to grow to 12.7 million by 2050.
