2 Fast-Approved Anti-Amyloid Alzheimer’s Drugs Raise Concerns

Over the past two years, two Alzheimer’s disease drugs were approved under accelerated approval. Both drugs are based on popular amyloid beta-plaque theories, yet both have raised questions.

The U.S. Food and Drug Administration, (FDA), approved Jan. 6. Leqembi (lecanemab-irmb), a new monoclonal antibody that seems to slow cognitive decline in some Alzheimer’s patients. In June 2021, Aduhelm (Aducanumab was approved.

Modest Cognitive Improvement

In 1984, researchers were the first to use this method. isolated the amyloid protein plaque that has since been identified as the primary sign of Alzheimer’s disease. Scientists have been searching for effective treatments to this fatal and disabling disease in the years that followed its discovery.

This has been the case until recently. It has yet to result in a single drug capable of slowing, stopping, or reverse cognitive decline. Although aducanumab was approved previously, it did not stop or slow down the progression of cognitive decline.

Lecanemab, which has just been approved by the FDA, is the first drug to show signs of cognitive decline in mild cognitive impairment patients in clinical trials.

The end result “indicates that thorough removal of beta-amyloid from the brain leads to clinical benefit,” Maria C. Carrillo, who holds a doctorate in neuroscience and is the chief science officer of the Alzheimer’s Association, said in an emailed statement to The Epoch Times.

The Phase 3 trial Lecanemab was the best-selling drug in this study. “moderately less decline” Measures of cognition and functioning were higher than those taken with a placebo after 18 months.

It’s important to note that only Phase 2 trial According to a, FDA approved the results. press release The drugmaker. Phase 2 only showed that lecanemab reduced brain plaques in 854 subjects, but did not assess whether cognitive improvement was possible. This is the same kind of data that led to aducanumab’s approval.

Researchers concluded that longer trials are needed to determine the new drug’s efficacy and safety in early Alzheimer’s disease.

“Some physicians may want to wait for the results of these longer and larger studies and for the medication to obtain full FDA approval before prescribing to their patients,” Dr. Zaldy Tan, who holds a master’s degree in public health and is the medical director of the Jona Goldrich Center for Alzheimer’s and Memory Disorders at Cedars-Sinai, told The Epoch Times.

Anyone who is unable to access Medicaid or Medicare and wants to use lecanemab will need to pay out-of-pocket. The cost is approximately estimated treatment cost The annual cost of the drug is $26,500, which puts it out of reach of many patients.

If lecanemab receives a second dose, “traditional FDA approval,” the Centers for Medicare and Medicaid Services (CMS) would provide broader coverage, CMS said in a statement.

Potentially severe side effects

In its approval of the drug by the FDA, prescribing instructions for lecanemab include a warning about amyloid related imaging abnormalities (ARIA), which are known to occur when there are antibodies of this class.

While ARIA typically don’t have symptoms, “serious and life-threatening events” It is possible. ARIA is often accompanied by temporary swelling in the brain. This may also be accompanied sometimes by bleeding in the brain. These usually disappear over time. Other symptoms include confusion, headaches, vision changes, nausea and seizure.

Lecanemab is also susceptible to infusion-related reactions such as nausea, vomiting, flu-like symptoms, changes in blood pressure, and changes in blood sugar.

ARIA, Infusion-related Reactions, and Headaches were the most frequently observed adverse events.

The deaths of three patients These risks could be associated with those who received the drug as an extension to the study.

Tan stated that this information is particularly important for people who take blood thinners or are carriers of the Apolipoprotein E gene. APOE4 allele, “who have been shown in the clinical trials to have higher rates of brain bleeding and swelling from lecanemab,” He elaborated.

“However, there will be a subset of persons with Alzheimer’s disease who would be willing to accept the expedited FDA review and approval,” Tan also added. “These patients will need to be monitored closely and their response to the medication tracked.”

Similarity to Aducanumab Controversy

Aducanumab was also granted accelerated approval as a monoclonal anti-bodio. approval by the FDA Its ability reduce amyloid plaques within the brain is its only benefit.

In March 2022, The Journal American Family Physician Publié an editorial explaining why doctors shouldn’t prescribe this Alzheimer’s treatment.

To determine if aducanumab was effective, the authors performed a meta-analysis of all available research. “statistically significant or clinically meaningful” Comparative testing of cognition revealed differences.

“… Thus, the FDA approval was based entirely on amyloid reduction and ignored the absence of a significant symptomatic benefit for patients,” The authors reached a conclusion.

The most important thing is the side effect The profile of this drug is very similar with that observed with lecanemab.

Aducanumab, which has a similar mechanism as lecanemab’s, caused damage that included ARIA, cerebral edema, and cerebral hemorhage in around 20% of patients.

Amyloid Research: Serious Questions

The successive approval of Alzheimer’s anti-amyloid antibody drugs brought hope, but whether their benefits outweigh the risks is still a question among scientists.

It is still unknown what the mechanism of action is for these drugs.

“For years, it was generally accepted that amyloid plaques, the insoluble proteins that are seen in the brains of persons with Alzheimer’s disease, [are] the main cause of the memory loss and inability to perform daily tasks,” Tan.

But he admits that treating amyloid hasn’t provided the benefits amyloid theory would suggest.

In July 2022 Science reported on doctored images in a series of influential studies on the association between amyloid plaques and Alzheimer’s disease.

An attorney investigating an experimental drug for Alzheimer’s called Simufilam hired Matthew Schrag, a neuroscientist and physician at Vanderbilt University. Schrag examined published images regarding the drug’s science and found duplicated or altered images within dozens of journal articles.

Authors to study “appeared to have composed figures by piecing together parts of photos from different experiments,” Elisabeth Bik was a molecular biologist who is also a well-known forensic imaging consultant. Science. “The obtained experimental results might not have been the desired results, and that data might have been changed to … better fit a hypothesis.”

But this doesn’t necessarily invalidate all previous research. There is. evidence that mutated genes This code can be used to identify precursors to amyloid protein, which causes the early onset. The Alzheimer’s Association This indicates that beta-amyloid protein may be a “prime suspect” The death and decline in brain cells.

Tan sees amyloid plaques as part of the problem.

“There are other abnormal proteins such as tau, alpha-synuclein, TDP-43, and processes such as inflammation and vascular disease that are involved,” He stated. “This discovery [of other abnormal proteins] will help guide future therapies and expand available treatments for Alzheimer’s disease.”

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