New Drug for Alzheimer Disease Shows Promise in Phase 3 Trial

WEDNESDAY, Sept. 28, 2022 (HealthDay) -- Japanese drugmaker Eisai on Wednesday said its experimental drug lecanemab helped slow thinking declines among people in the early stages of Alzheimer disease.

The findings from a phase 3 clinical trial have yet to be peer-reviewed in any medical journal. But according to a company news release, "lecanemab treatment met the primary end point and reduced clinical decline on the global cognitive and functional scale, CDR-SB, compared with placebo at 18 months, by 27 percent."

The new trial included almost 1,800 patients with early-stage Alzheimer disease whose progress was tracked over 18 months. Investigators tracked cognition using the CDR-SB scale, which Eisai said is "used to quantify the various severity of symptoms of dementia." Twenty-five percent of the participants were either Black or Hispanic.

Compared with patients taking a placebo, those who got lecanemab saw a "significant" slowing of cognitive decline as measured by the CDR-SB scale, Eisai reported. Noticeable changes in the rate of decline began as early as six months after taking the drug. Positron emission tomography scans of the brains of patients who took lecanemab also showed noticeable declines in levels of the amyloid protein plaques, which have long been a hallmark of Alzheimer disease, Eisai noted.

As to possible side effects, there was a slight uptick in drug users of cerebral hemorrhages known as "amyloid-related imaging abnormalities," with 21.3 percent of lecanemab users experiencing this issue compared with 9.3 percent of those who took placebo.

Lecanemab is a monoclonal antibody drug that is designed to target and help remove Alzheimer disease-associated amyloid plaques in the brain. According to Eisai, in July, the drug was placed on an "accelerated approval pathway and granted priority review" by the U.S. Food and Drug Administration. That may help speed the drug's path to approval. Eisai plans to present the full phase 3 clinical trial data in late November "at the Clinical Trials on Alzheimer's Congress, and publish the findings in a peer-reviewed medical journal," the company said.

More Information

Alzheimer's Association Statement