On July 6, the U.S. Food and Drug Administration (FDA) approved Leqembi (lecanemab-irmb), a therapy for Alzheimer’s disease shown to slow the cognitive decline associated with the disease. Previously, the FDA approved lecanemab through an accelerated approval pathway in January 2022. Lecanemab is the first amyloid beta-directed antibody to be converted from a FDA accelerated approval to a traditional approval for the treatment of Alzheimer’s disease. The drug works by reducing amyloid plaques that form in the brain and is used in patients with mild cognitive impairment (MCI) or mild dementia stage of Alzheimer’s disease.
Read the July 6, 2023 FDA news release
Lecanemab and AHEAD study at UW–Madison
Cynthia Carlsson, MD, MS, Director of Wisconsin Alzheimer’s Institute, leads the AHEAD study at UW–Madison. The study is one of 100 global research sites currently offering a clinical study of investigational treatment of lecanemab in people who may be at risk for memory problems. Dr. Carlsson spoke to multiple media outlets after the FDA lecanemab approval annoucement. She emphasized the treatment will only be approved for people who are diagnosed with mild cognitive impairment or mild dementia and also meet other limited criteria. She said while this news is an important advance in the treatment of Alzheimer’s disease, researchers remain dedicated to discovering treatments that will stabilize the disease and ideally, prevent it from happening.
Read and watch the interviews with Dr. Carlsson in the links below:
“AHEAD Study: Wisconsin participates in global effort to tackle Alzheimer’s” – CBS 58, Milwaukee, Wisconsin
“UW Health recruiting volunteers for clinical study of new Alzheimer’s drug” – WKOW Channel 27, Madison, Wisconsin
“Wisconsin doctor weighs in on new Alzheimer’s drug” – Spectrum News 1, Milwaukee, Wisconsin
“Madison school studying new Alzheimer’s drug” – WEAU 13 News, Eau Claire, Wisconsin
“FDA grants full approval for drug aiming to slow progression of Alzheimer’s disease” – NBC 15, Madison, Wisconsin
“FDA approval of groundbreaking Alzheimer’s drug brings new hope to patients, caregivers” – Fox11 WLUK, Green Bay, Wisconsin