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Second Trial Participant Dies in Alzheimer’s Drug Study

Neurology
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Alzheimer’s Disease

— “All eyes are on lecanemab,” a closely watched anti-amyloid treatment

By
Judy George, Deputy Manager, MedPage Today
November 28, 2022

A death linked to lecanemab treatment was reported just days before promising data from the phase III trial of lecanemab.

Science published an unpublished case study that suggests the death of a 65 year-old participant in the lecanemab trials. This patient also suffered from cerebral amyloid, which is a condition where amyloid builds-up in the blood vessels of the brain. The drug’s interaction with a blood thinner may have contributed to the death.

This is the second publically discussed death of a lecanemab trial patient. STAT reported that an elderly man died in October from a brain hemorhage. The death may have been caused by an interaction between lecanemab, Eliquis (a blood thinner), but lecanemab developer Eisai claimed it was not.

Lecanemab could be the most closely monitored treatment in the Alzheimer’s drug development pipeline. In September Eisai and Biogen published a press statement stating that the phase III CLARITY trial for lecanemab achieved its primary endpoint. This included a statistically significant decline in clinical symptoms in patients with early Alzheimer’s disease. According to the companies’ statements, the drug’s profile of amyloid related imaging abnormalities (ARIA), brain edema or small bleeding that may occur after amyloid has been cleared was within expectations.

The full data from the trial will be presented at the annual 2022 Clinical Trials on Alzheimer’s Disease conference.

Jason Karlawish MD of Penn Memory Center at University of Pennsylvania in Philadelphia stated that “all eyes are on lecanemab” because a press release shows the drug’s benefits compared to placebo across all primary as well as secondary endpoints.

Karlawish stated that if the data are valid, it is an effective treatment. “But, it’s also an effective treatment that we knew had risks, ARIA risks. These case reports on patient deaths further enhance our knowledge about the drug’s risks.

Karlawish stated that if the FDA approves the drug for slowing cognitive decline, they may consider a risk evaluation strategy and mitigation strategy (REMS). He stated that REMS could “thread a number of complicated needles together.”

Even though the trial data were positive, it is still a concern to see how the drug interacts in real-world patients. Robert Howard, MD. MRCPsych from University College London in England stated, “The shift from clinical trials where participants are carefully screened, selected to exclude the existence of accompanying conditions that increase the risk of side effects,”

Madhav Thambisetty, MD and PhD of the National Institute on Aging said, “It’s crucial that we analyze all available clinical trial data and make it publically available to researchers so that we can identify individuals at greatest risk for serious, potentially life-threatening adverse effects after exposure to lecanemab or other drugs in this category.” He also co-authored a preprint with Howard outlining some questions that remain to be answered about anti-amyloid Alzheimer’s therapies.

Lon Schneider MD of the University of Southern California in Los Angeles said that it is not a forgone conclusion the CLARITY trials results are clinically meaningful.

Schneider explained to MedPage Today, “The question here is whether there’s clinically meaningful efficacy.

Schneider stated, “We haven’t seen the protocol specified subset analyses — who might be benefited to an meaningful extent, dropouts, and the likelihood for potential biases.” This is necessary to evaluate side effects.

Judy George covers neurology and neuroscience news for MedPage Today, writing about brain aging, Alzheimer’s, dementia, MS, rare diseases, epilepsy, autism, headache, stroke, Parkinson’s, ALS, concussion, CTE, sleep, pain, and more. Follow

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