Alzheimer’s Drug Lecanemab Slows Cognitive Decline at Cost of Side-Effects, Shows Clinical Trial
On November 29, 2022, Eisai and Biogen released the full results of their phase III-experimental Alzheimer’s drug, lecanemab. The clinical trial dubbed ‘Clarity AD’, lasted 18 months and studied nearly 1,800 patients with Alzheimer’s disease.
The results from the trial showed a slowing of disease progression by 7.5 months compared to the placebo group and a 27% slow in decline by the clinical dementia rating (CDR) scale.
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However, the study also reported adverse events: 17.3% of patients given the drug having bleeding in the brain (ARIA-H) and 12.6% having cerebral edema (ARIA-E), a form of swelling in the brain.
According to Eisai and Biogen, the adverse event ARIA-E is a commonly a temporary swelling in areas of the brain that usually resolves over time. Bleeding can also potentially occur in small spots of the brain (ARIA-H) with the swelling.
Biogen said: “Although most people with ARIA-E do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes and nausea.”
Ronald Petersen, director of the Mayo Alzheimer's Disease Research Center, said "All of these amyloid-lowering drugs carry a risk for increased brain hemorrhage," speaking to Reuters. "I think the primary outcomes, the secondary outcomes, the amyloid-lowering is pretty impressive."
Lecanemab is a humanised monoclonal antibody therapeutic that works by removing amyloid-beta, a component of the amyloid plaques which are thought to be a causing factor in the development of Alzheimer’s disease.
“Today’s 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, Chief Executive Officer at Biogen.
The release of the full results comes after the US FDA authorised lecanemab for accelerated priority review in July 2022. According to Eisai, Biogen, and the FDA, these results “serve as the confirmatory study to verify the clinical benefit of lecanemab.”
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