Donanemab Significantly Slows Progression of Alzheimer ’s Disease, Study Finds

The drug donanemab significantly slowed the clinical progression of Alzheimer ’s disease among patients with mild cognitive impairment or mild dementia, according to astudy published yesterday inJAMA.Donanemab is an antibody designed to target and remove beta-amyloid proteins that have clumped together to form plaques in the brain. It is manufactured by Eli Lilly and Company, which stated in anews release that it has submitted the drug for U.S. Food and Drug Administration (FDA) approval and expects regulatory action by the end of this year. Eli Lilly funded the study.John Sims, M.D., of Eli Lilly and colleagues conducted a phase 3 randomized clinical trial including participants aged 60 to 85 years with early symptomatic Alzheimer ’s disease who had amyloid and tau pathology (abnormal tau proteins and amyloid plaque are considered markers of Alzheimer’s). Participants were randomized to receive either donanemab (700 mg for the first three doses and 1,400 mg thereafter) or placebo, administered intravenously every four wee ks for up to 72 weeks.The study participants received MRIs at 4, 12, 24, 52, and 76 weeks to monitor amyloid plaque abnormalities, with additional MRIs scheduled at investigators ’ discretion. (Amyloid-related imaging abnormalities—which can result in headache, confusion, as well as more severe symptoms—are associated with investigational interventions targeting amyloid proteins.)Participants ’ cognition and daily functioning were assessed usi...
Source: Psychiatr News - Category: Psychiatry Tags: Alzheimer ' s disease amyloid plaques antibody disease progression donanemab Eli Lilly JAMA Source Type: research