Clinical trial for first Alzheimer’s drug with effect on cognitive decline seeks South Texas recruits

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UT Health San Antonio’s Glen Biggs Institute for Alzheimer’s and Neurodegenerative Diseases is participating in a national clinical trial to assess whether a drug, lecanemab, can prevent or slow the onset of Alzheimer’s disease in patients who are not yet symptomatic.

Lecanemab, an antibody, was recently shown to be able to slow cognitive decline by 27% in people in the early stages of Alzheimer’s disease, according to a study published in the New England Journal of Medicine (NEJM).

Today, in partnership with the UTRGV, the Biggs Institute is one of several dozen Alzheimer’s research centers in the United States working on a clinical trial to see if lecanemab can slow the decline. cognitive in people who have the markers of Alzheimer’s disease but who do not yet suffer from it. symptoms. Indeed, a protein associated with Alzheimer’s disease, amyloid, can be detected 10 or 20 years before the onset of any cognitive decline.

Together they are looking for volunteers who meet these criteria between 55 and 80 years old to participate in the clinical trial.

Dr. Arash Salardini is the Kleese Foundation Distinguished Chair in Alzheimer’s Disease and Neurodegenerative Diseases and Clinical Trial Principal Investigator at the Biggs Institute. He said they were testing the drug on patients who don’t show symptoms of Alzheimer’s disease.

“Now what we want to do, and this is also a national trial, is apply this before people show symptoms, so while their immune systems are functioning at their best,” he said. “The idea is that if you can stop this amyloid and remove this amyloid before people show symptoms, you can preserve a lot of their cognition.”

The hope, Salardini said, is that because the immune system is still at full strength in these patients, cognitive decline can be slowed even further and produce even better outcomes.

Although lecanemab produced positive results for many clinical trial participants in the NEJM study, it is important to note its shortcomings and potential harmful effects.

The drug is not intended to completely stop or reverse cognitive decline, but simply to slow it down. Lecanemab also has potentially harmful side effects – brain inflammation and brain bleeding – as a result of an amyloid-related imaging abnormality (ARIA). There were also two patient deaths during the initial lecanemab study, or 0.2% of the 898 patients taking the drug.

Salardini acknowledged that while there are certainly benefits to participating in the clinical trial – gaining access to a clinical drug for Alzheimer’s disease and advancing scientific understanding of the disease – potential volunteers should understand that there is a certain level of risk they would take.

“We have mechanisms to try to mitigate this [from] that’s going on, and the monitoring that we’re doing to minimize that, but we can’t minimize [risk] to zero,” Salardini said.

This clinical trial will be a double-blind study involving approximately 1,400 patients. A control group of patients receives a placebo and an experimental group of patients receives lecanemab. Neither patients nor researchers will know who gets what. These double-blind studies aim to prevent bias from affecting the results, a rigorous research method.

Salardini said the Biggs Institute was only a small part of the study and was looking for 20 to 40 volunteers from the South Texas area. He said a big advantage of being in South Texas is that they hope to attract more Latino attendees.

“Diversity is not just a kind of political thing that we try to be inclusive of, it actually makes science applicable to all populations that have been recruited,” he said. “We’re … in the lucky situation where we have a very vital, very vibrant, fairly educated Mexican-American population here in San Antonio, and I think having them in the trial would just make the results much more meaningful.”

To be clear, all humans have nearly identical DNA, there is much more genetic variation within races and ethnicities than between themand there is no genetic basis for the breed. But the diversity of populations in studies like these is important because minor genetic differences based on geographic origin can affect the impact of diseases and treatments on certain populations.

Salardini has made it clear that lecanemab is unlikely to be a miracle drug for curing Alzheimer’s disease, and researchers still have many questions about the ultimate effectiveness of a drug like lecanemab — an editorial in the journal scientific The Lancet warned against overestimating the impact of the drug for many reasons, such as potentially prohibitive cost, harmful side effects, difficulty administering the drug in poorer countries, and whether it slows cognitive decline enough to be clinically meaningful.

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

“Another one of those unsolvable issues at one time was HIV,” he said. “But once they found the first drug – which was AZT – they had a good idea of ​​what the mechanism was, so they could develop combination therapies that now make HIV no not an acute, fatal disease, but more of a chronic, somewhat manageable disease, and that’s the kind of thing we want for Alzheimer’s disease.