Alzheimer’s treatment slows mental decline in clinical trial

A new treatment called lecanemab slowed the rate of cognitive decline in people with the disease. Alzheimer’s 27% in a clinical trial. The statement was published by Tokyo-based drugmaker Eisai, who developed the new treatment in partnership with biotech company Biogen in Cambridge, Massachusetts (USA).

The product is a monoclonal antibody designed to clear clumps of beta-amyloid protein that many believe are at the root of Alzheimer’s disease. The theory, known as the “amyloid hypothesis,” proposes that this protein accumulates in toxic deposits as the disease progresses, causing dementia.

But some in the scientific and medical community are hesitant. According to them, more data is needed than the paper offers. If the results hold, the treatment will be the first of its kind to show a strong signal of cognitive benefit in a robust study.

The results are “pretty promising,” according to Caleb Alexander, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health and a member of the US Food and Drug Administration (FDA) advisory board (a country agency similar to ANVISA).

The expert noted that although the results show that lecanemab provides some clinical benefit, “the degree to which it does so is small.”

This is because, according to George Perry, a neurobiologist at the University of Texas who is skeptical of the company’s progress, the amyloid protein is “related to the problem, but not the ‘issue’.”

But for the tens of millions of patients living with Alzheimer’s, even a modest benefit can be significant. “These are the most encouraging results to date in clinical trials addressing the underlying causes of Alzheimer’s disease,” the Alzheimer’s Association said in a statement.

In 2021, the FDA controversially approved aducanumab, another biogen-developed monoclonal antibody, to treat Alzheimer’s disease – with no clear signs of cognitive benefit.

Lecanemab, known by the trade name Clarity AD, worked non-stop for a full 18 months and statistically significantly slowed the decline. The published results describe a study of nearly 1,800 people with early-stage Alzheimer’s from more than a dozen countries.

During the study, patients were given biweekly intravenous infusions of either lecanemab or a placebo, and the treatment reduced amyloid in the brains of the treated subjects. According to Rob Howard, a psychiatrist at University College London, it’s “a very small and almost imperceptible difference from placebo.”

The FDA expects to announce its decision on lecanemab on January 6.