In a potentially significant breakthrough in the treatment of Alzheimer’s disease, recently completed clinical trials show a new experimental drug treatment could significantly slow the progression of the disease in the early stages.
Japanese drugmaker Eisai Co. Ltd. and its U.S. partner Biogen Inc, announced that Eisai’s large global Phase 3 Clarity AD clinical trial confirmed positive results of lecanemab in treating early Alzheimer’s. Lecanemab is an investigational anti-amyloid beta protofibril antibody for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s with confirmed presence of amyloid pathology in the brain.
The Phase 3 trial was a placebo controlled, randomized study of 1,795 people with early Alzheimer’s disease over a period of 18 months. The results of the trial found that those who took the lecanemab treatment saw a 27% reduction in cognitive and functional decline, compared to those in the placebo group.
The announcement gives “patients and their families hope that lecanemab, if approved, can potentially slow the progression of Alzheimer’s disease, and provide a clinically meaningful impact on cognition and function,” said Michel Vounatsos, CEO of Biogen, in a news release.
“Importantly, the study shows that removal of aggregated amyloid beta in the brain is associated with a slowing of disease in patients at the early stage of the disease,” he said.
In a statement, the Alzheimer’s Association, which represents the 6 million people living with Alzheimer’s, called the positive findings of the lecanamab clinical trials “the most encouraging results in treating the underlying causes of Alzheimer’s to date.”
“For people in the earliest stages of Alzheimer’s, this treatment has the potential to change the course of the disease in a clinically meaningful way,” the statement read. “These results indicate lecanamab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions.”
Eisai will present the Clarity AD study results on Nov. 29 at the Clinical Trials on Alzheimer’s Congress and publish the findings in a peer-reviewed medical journal. They hope to get expedited FDA approval for use of the drug in January.