Alzheimer’s drug’s accelerated approval leads to deadly stroke

Ever hear the expression, “Out of the frying pan, into the fire”?

It means trading one bad thing for something else even worse.

In healthcare, that expression would apply when a drug meant to treat a disease carries side effects far worse than the disease itself.

That’s exactly the case with a newly approved drug for Alzheimer’s disease.

Unfortunately, the “fire” is fatal.

Lecanemab: hopeful Alzheimer’s drug turns deadly

In January of this year, the FDA approved the drug lecanemab for the treatment of early Alzheimer’s disease.

Lecanemab is not a cure for the disease. Rather, it attacks β-amyloid plaque buildup in the brains of patients with Alzheimer’s.

The most widely accepted theory for the cause of Alzheimer’s is known as the “amyloid cascade hypothesis.” This theory states that excess β-amyloid deposits neurotoxins in the brain, causing degeneration and loss of neurons.

The Alzheimer’s Association website states that headache is the most common side effect of lecanemab, as well as reactions to the intravenous infusions through which the drug is administered.

Unfortunately, further clinical trials have proven the side effects to be far worse…

How lecanemab was approved

The FDA has an approval process known as “accelerated approval” that allows a promising new drug to be approved for use if it has shown signs in clinical trials that it might be beneficial for patients with life-threatening diseases, or diseases for which other treatments do not exist.

Once the drug is on the market, further testing of the drug is required to confirm that it really works and that it is safe.

Lecanemab was approved through the accelerated approval process, and further testing is ongoing.

It was one of these tests that revealed a deadly side effect…

Accelerated approval turns deadly

A participant in a Phase III study of the efficacy and safety of lecanemab died after only three infusions of the drug. This had never happened in any previous trials.

Four days after the last infusion, the 65-year-old woman experienced stroke symptoms and died several days later due to multifocal intracerebral hemorrhage (brain bleeding in several locations) despite attempts at therapeutic intervention.

Although the woman had no cardiovascular predisposition to stroke, examination of her brain in an autopsy confirmed that the attack waged on β-amyloid by lecanemab also induced a similar phagocytic attack on the small blood vessels of her cerebral cortex that were also full of plaque.

The result was brain hemorrhage and stroke that could not be survived, despite immediate intervention. The drug reached its target — partial clearing of plaques and tau — but at the expense of massive damage to collateral smaller blood vessels and her death.

Co-investigator Dr. Pouya Jamshidi of the Department of Pathology at Northwestern University Feinberg School of Medicine, cautions, “Although this is the first reported case detailing the neuropathologic findings in response to lecanemab, the pattern and distribution of pathology are so striking it is inconceivable to believe this would be an isolated occurrence.”

Available at a pharmacy near you this summer

Even in light of the woman’s tragic death, and the admittance that the drug’s benefits are modest, it doesn’t appear that it will be pulled from the market.

Instead, recommendations have been made to screen patients for cerebrovascular disease and apolipoprotein E status before prescribing and that “the patient may need to be told that anticoagulant treatment for stroke, should such an event occur, may become an option with even greater risk.”

On June 9, 2023, an advisory panel for the US FDA voted unanimously that the drug shows “clinical benefit” for the treatment of Alzheimer’s, paving the way for a full FDA approval expected to come as early as July 2023.

If it were me, I’d be asking my doctor a LOT of questions before taking a drug that had gone through the accelerated approval process. And even then, I’d carefully weigh the options before I agreed to participate in a trial of a drug that had yet to be fully approved.

Thankfully, much research indicates we do have some safer options when it comes to the risk of Alzheimer’s. Though they are certainly not drugs or cures, there are a few natural standouts to support your brain health…

Vitamin D—This common vitamin just may be dementia repellant. And a study based on standardized clinical research data has helped zero in on segments of the population that could benefit the most from supplementing.

Omega-3 fatty acids — Tons of research show omega-3s have the potential to stave off Alzheimer’s disease, even helping the immune system to clear amyloid plaques. But a clinical trial in 2020 found dosage matters.

Niacin — A member of the B family of vitamins, researchers learned more than a decade ago that dietary niacin was protective against Alzheimer’s disease. Deficiency is common among older people with dementia.

Sources:

Case study reveals potentially lethal side effects of lecanemab for treatment of Alzheimer’s disease — Eureka Alert

Neuropathology of Anti-Amyloid-β Immunotherapy: A Case Report — Press Content Library

Lecanemab Approved for Treatment of Early Alzheimer’s Disease — Alzheimer’s Association

FDA advisers vote that lecanemab shows benefit as an Alzheimer’s treatment — CNN Health