How Effective Are Newly Approved Drugs in Treating Alzheimer’s?

Summary: More than a century of extensive research into Alzheimer’s has failed to deliver effective disease treatment or cure. Nevertheless, in the last few years, the US FDA has approved some disease-modifying drugs for the first time. However, real-world experience shows that they are only moderately good at slowing down the progress of the disease.

 Alois Alzheimer, a German Neurologist, first reported the case of a strange kind of dementia, with the formation of plaques in the brain in 1906. After that, he reported multiple such cases characterized by progressive loss of memory, personality changes, and death in a few years. This could be regarded as the beginning of modern research into the condition.

It means that more than 100 years have passed, and Alzheimer’s cure is as elusive as ever. Even worse, few drugs can provide any relief to the patients or slow down their progress.

For almost 100 years, Alzheimer’s treatment has been mainly symptomatic, providing relief from issues like sleep disturbances and behavioral issues in the patients. Few drugs are given to change the course of the disease, but they do not have any significant impact.

Even more worrisome is the rise of the disease. A century ago, it was a rare condition, but now among the top 10 causes of death in the US. In 2019, there were reported 57 million cases of Alzheimer’s, and these numbers are expected to cross 150 million by 2050.

Fortunately, things are getting better, and in recent years, for the first time, the US FDA has approved the so-called disease-modifying drugs. Surely, these drugs are not intended to cure Alzheimer’s. However, they are intended to slow down the disease’s progress, thus preventing disease-related disabilities and prolonging the lifespan of those living with the conditions. These new drugs are just a small step in the right direction. However, many experts think these are very tiny steps and might not make a significant difference.

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What these drugs try to do is remove faulty proteins, that is, beta-amyloid and tau proteins, from the brain. It is an accumulation of these faulty proteins that leads to the death of brain cells. Science has created a few biologics that can help remove these proteins.

One of the first drugs to get US FDA approval was aducanumab. It was approved by the US FDA in 2021. However, later, it was withdrawn due to inconsistent results. Since then, the US FDA has approved two other anti-amyloid antibodies, lecanemab-irmb and donanemab. Approval of these two drugs has been seen as groundbreaking, as disease-modifying drugs were improved for the first time.

However, it would be right to say that these drugs did not live up to the expectation. The truth is that, even in clinical studies, they showed modest benefits. Nevertheless, researchers are highly excited since they think these are small steps in the right direction.

These drugs are not expected to cure Alzheimer’s in any way. This is because they merely target amyloid plaques. Although it is known that amyloid plaque accumulation plays a role in the disease progression, its exact place in the disease development is unclear. Studies show that these drugs generally help only when started early enough. However, if the treatment is started in the later stages, it might be less effective.

Here, it is worth noticing that even in clinical trials, drugs like lecanemab and donanemab showed a moderate 27% and 36% slower decline in cognitive function compared to placebo. Moreover, these trials were company-sponsored trials.

Many researchers have even challenged these findings. Critics say that the overall impact of these drugs is too little to be considered meaningful. Further, when researchers used other scales to measure the benefits, they found that benefits were much less than reported in clinical studies. In real life, these drugs slow cognitive decline by just about 15%, much less than that reported in initial clinical studies.

Finally, it is worth noticing that these drugs are quite expensive, with therapy for a year costing more than 30,000 USD. These drugs also cause many side effects. More than half of all patients report side effects with these medications.

To sum up, although researchers are excited about these drugs, as they are the first medications with disease-modifying effects, they have very little benefit in real-world conditions. Nonetheless, this is just the beginning, and we may see an introduction of safer and more effective drugs in the near future.