Clinical trial of first Alzheimer’s drug to affect cognitive decline looks for South Texas recruits

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The Glen Biggs Institute for Alzheimer’s and Neurodegenerative Diseases at UT Health San Antonio is conducting a nationwide clinical trial evaluating whether the drug lecanemab can prevent or delay the onset of Alzheimer’s disease in asymptomatic patients. I am joining.

The antibody lecanemab was recently found to slow cognitive decline by 27% in people with early-stage Alzheimer’s disease. Research published in New England Journal of Medicine (NEJM).

The Biggs Institute is currently working in partnership with UTRGV on a clinical trial to see if lecanemab can slow cognitive decline in individuals who have markers of Alzheimer’s disease but have not yet experienced it. It is one of dozens of Alzheimer’s disease research centers. symptoms. This is because amyloid, a protein associated with Alzheimer’s disease, can be detected 10 or 20 years before cognitive decline begins.

together they We are looking for people who meet the conditions from 55 to 80 years old Participate in a clinical trial.

Dr. Arash Salardini is the Kleese Foundation Distinguished Chair for Alzheimer’s and Neurodegenerative Diseases and Principal Investigator of Clinical Trials at the Biggs Institute. He said they are testing the drug on patients who are not experiencing symptoms of Alzheimer’s disease.

“Now what we want to do is apply this, which is also a national trial, before people develop symptoms and while their immune systems are functioning at their best.” The idea is that if we can stop amyloid and get rid of this amyloid before symptoms appear, we can preserve much of our cognition.”

Salardini said these patients’ immune systems are still intact, so it’s hoped that cognitive decline will be delayed even further, leading to better outcomes.

Although lecanemab produced positive results for many of the clinical trial participants in the NEJM study, it is important to be aware of its drawbacks and potential harms.

This drug is not intended to completely stop or reverse cognitive decline, it only slows its progression. Lecanemab is also associated with potentially harmful side effects (brain inflammation and intracerebral hemorrhage) as a result of amyloid-associated imaging abnormalities (ARIA). Two of her patients also died during the first study of lecanemab. This represents her 0.2% of her 898 patients who were on lecanemab.

Salardini said that while participating in clinical trials does have the advantage of gaining access to clinical medicines for Alzheimer’s disease and improving the scientific understanding of the disease, potential volunteers have some I acknowledged that I need to understand that there are risks.

“We have mechanisms to try to mitigate that [from] A monitor to minimize it, but it can’t be minimized [risk] Bring it down to zero,” Salardini said.

This clinical trial is a double-blind trial involving approximately 1,400 patients. Patients in the control arm will receive placebo and patients in the arm will receive lecanemab. Neither patients nor researchers know who is receiving what. These double-blind studies work to prevent bias from affecting results. This is a rigorous research method.

The Biggs Institute is only a small part of the study, according to Salardini, and is recruiting 20 to 40 volunteers from the South Texas area. He said one of the big advantages of being in South Texas, he said, is that he hopes to be able to bring in more Latinx attendees.

“Diversity is not just a political thing we try to include, it actually makes science applicable to all recruited populations,” he said. We’re fortunate to have some very dynamic, very dynamic, very educated Mexican Americans here in San Antonio, and having them on board makes the results more meaningful. I think it will be

For clarity, All humans have nearly identical DNA, Much more genetic variation within races and ethnicities than between races and ethnicitiesWhen Race has no genetic basisDiverse populations are important in such studies, however, as subtle genetic differences based on geographic origin can affect the impact of diseases and treatments on particular populations.

Salardini revealed that lecanemab is likely not the miracle drug to treat Alzheimer’s disease.And many questions still remain among researchers about the ultimate efficacy of drugs like lecanemab – Science Journal Editorial lancet Be careful not to exaggerate the effects of drugs There are many reasons, including its potentially prohibitive cost, harmful side effects, difficulty of administration in poorer countries, and whether it actually slows cognitive decline and is clinically meaningful.

But in the same editorial, its authors said lecanemab could pave the way for new drugs.

“Another of these intractable problems at some stage was HIV,” he said. “But once the first drug, AZT, was discovered, we had a better idea of ​​what the mechanism was. So combination therapy became possible, and HIV is now not a fatal acute disease, but a chronic, mild disease. It’s become manageable, and that’s what we want for Alzheimer’s disease.”