BOSTON, MA – September 26, 2022 – The new Alzheimer’s drug Lecanemab significantly slowed the rate of cognitive decline in patients with early-stage disease according to a study published September 26th in the New England Journal of Medicine. Dr Babek Tousi, the lead investigator at the Cleveland Clinic study site, opined, “finally we may have a medication that is showing efficacy in this primary outcome of this study.”
Dr. Christopher Van Dyck, the director of the Yale Alzheimer’s Disease Research Center, presented the results at a medical meeting in San Francisco. He said that “Lecanemab reduced markers of amyloid in early Alzheimer’s disease and resulted in less decline than placebo on all measures of cognition and function at 18 months.” The new drug Lecanemab (developed at 2 pharmaceutical companies) is an anti-amyloid antibody that helps remove amyloid plaques. Amyloid is a protein that accumulates in the brain of people afflicted with Alzheimer’s disease. It binds with tau protein to form plaques that can affect brain cell function and cause loss of memory and confusion, the hallmark symptoms of Alzheimer’s disease.
Hundreds of anti-amyloid drugs have been trialed or are in the midst of clinical studies, most with discouraging results. Biogen’s drug Aducanumab created much noise with a recent controversial study that, nevertheless, won accelerated FDA approval. However, the drug was not covered by Medicare due to its high price, unwanted complications and a strong belief that there was little evidence that it slowed cognitive impairment in early Alzheimer’s disease.
1,800 people with mild Alzheimer’s disease were enrolled in the study. Participants were assigned to either the drug treatment group or the placebo group. Approximately 25% of the participants were from minority groups, which was comparable to the Medicare population. The drug was administered intravenously, twice a week. The side-effects of treatment with Lecanemab included brain swelling or brain bleeding in about 20% of the patients. Most of these people were asymptomatic. The adverse effects were significantly more than the 9% occurrence rate in the placebo group. However, this complication occurred less frequently than in patients taking Aducanumab in the Aducanumab study.
The pharmaceutical companies have already applied for an accelerated FDA approval to authorize the use of Lecanemab. A decision is expected in January. Full approval will require longer clinical trials.
If the drug gets FDA approval, then cost may be a concern. The cost of the controversial anti-amyloid medicine Aducanumab is $28 thousand a year.
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