The study included 257 patients with early therapeutic Alzheimer’s disease; 131 got Donneb, while 126 got placebo. The researchers found that Donenemab slowed cognitive and daily functional decline by 327% after 76 weeks in Alzheimer’s patients, compared with those who received a placebo.
Not involved in this research, Maria Carrillo, chief science officer of the Alzheimer’s Association, noted that, over a period of more than 18 months, a decline૨% slowdown could be significantly effective for Alzheimer’s patients.
“At 18 months, these people were declining at a slower rate for six months, compared to people who didn’t get the drug,” Carillo said. “It’s six months with your family, a better understanding, a better memory, a more enjoyable time.”
Decreases were measured using the Integrated Alzheimer’s Disease Rating Scale, which measures both cognitive and functional capacity, such as memory and ability to perform daily tasks.
Carillo said the results of the Phase 2 trial are early, but promising, and present some very strong data on a drug’s ability to slow the progression of Alzheimer’s disease.
“There’s a lot of potential in this,” Carillo added. “A more significant slowdown, or shutdown, at this earlier stage may be the first step toward cognitive decline, which will be truly transformative for our field.”
The researchers also looked at the effect of the drug on the formation of amyloid beta plaque and ta prote proteins, which are thought to be a symptom of Alzheimer’s disease.
At 52 weeks, approximately 60% of participants reached amyloid-negative status, meaning that their levels were at the level of otherwise healthy people. At Weeks 76 weeks, amyloid plaque levels – measured in centilloids – dropped to 85 centilloids compared to those receiving placebo, the researchers said.
Patients who reached this low level of amyloid beta plaque were given a placebo with donamemb.
Slow disease
“Once these participants cleared the amyloid in the brain, the drug was removed, and it continued to slow down,” Carillo said. “It’s important because then you don’t have to constantly monitor for any safety or adverse events.”
Participants who received donneb also showed a greater reduction in overall tau weight than those who received placebo.
Carillo said the study was unique in that it examined participants for the presence of both amyloid beta plaques and tau before entering the hearing.
Some researchers in the field believe that “if you stop amyloid early, and you slow down that rhythm, you can slow down Alzheimer’s,” Carillo said. “This is trying to show that paper, and this is the very first time we’ve seen this.”
Research on donamenb is still early, and researchers say longer and larger tests are needed to determine the safety and effectiveness of the drug.
“We are very excited about these positive findings for Donenemb as a potential treatment for people living with Alzheimer’s disease, the only leading cause of death without treatment that slows the progression of the disease,” said Dr. Eli Lilly, Vice President of Grief and Neurodegeneration. , Said in a statement in January announcing the trial results. Additional, ongoing research aims to mimic the findings, Mintu said.
There are no new valid treatments since 2004
U.S. The new Alzheimer’s drug has not been approved by the Food and Drug Administration since 2004. The experimental Alzheimer’s drug Edukanumab, developed by pharmaceutical company Biogen and its Japanese partner ISI, is currently under review by the FDA.
In conjunction with this buildup associated with the progression of Alzheimer’s disease, many Alzheimer’s candidates aim to target amyloid beta plaques and protein proteins. The goal with drugs such as donenamb is not to cure the disease, but to maintain a person’s memory and comprehension for a long time.
Alzheimer’s disease is the most common form of dementia and currently affects 6.2 million Americans aged 65 and over, according to the Alzheimer’s Association. U.S. Department of Disease Control and Prevention Centers say that number is expected to reach at least 14 million by 2060.
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