Nobody wants a cure for Alzheimer’s more than we do, and recent news about a new drug sparked excitement in our office, among our patients and around the world.

In December, the FDA gave accelerated approval to lecanemab (name brand Lequembi) for the treatment of mild Alzheimer’s. The drug reduces amyloid deposits – or “plaque” – in the brain. Lecanemab affects the pathology of the disease – the plaque – rather than the symptoms, as other medications have done.

Is this a breakthrough?

Well, it’s a step. Lecanimab reduces plaque by a statistically significant factor. This means imaging studies show less plaque in the brains of patients taking the drug. However, reducing plaque doesn’t seem to affect cognitive function by a clinically meaningful factor. The patient may have less plaque, but they don’t have less symptoms of dementia.

You may have heard reports that after 18 months on lecanemab treatment, researchers found a 27% slowing of disease progression. The report was based on a very modest change in decline on a scale of cognitive and functional abilities. It remains highly debatable that this represents meaningful change for patients and families.

So why did the FDA approve a drug that has questionable benefit? The FDA is inclined to approve drugs for diseases that lack treatment, if the drug achieves some biological change that may be helpful. Since it’s proven to reduce plaque, it was granted accelerated approval. The next step is to prove effectiveness, and the outcome will either lead to withdrawal of the drug or to full approval. If fully approved, insurers will be more inclined to cover the cost – but currently most do not.

We believe a doctor has the responsibility to guide treatment decisions. In addition to the questionable benefits and expense of lecanemab, there are considerable risks — among them life-threatening brain swelling and bleeding.

Based on the research at the time of this writing, we do not support the use of lecanemab for most patients. However, we remain hopeful that this is a step forward. There are currently 145 drugs in development across 170 research trials, and we are watching all of them – eager, like you, for a true breakthrough.