Class I study shows single doses of aducanumab safe, well tolerated; class II studies show reduced amyloid deposition on brain PET at one year
THURSDAY, March 3, 2022 (HealthDay News) — The evidence for use of aducanumab in individuals with early symptomatic Alzheimer disease is presented in a report from the American Academy of Neurology Guidelines subcommittee published online Feb. 23 in Neurology.
Gregory S. Day, M.D., from the Mayo Clinic in Jacksonville, Florida, and colleagues conducted a systematic review of available clinical trial data detailing aducanumab use in individuals with early symptomatic Alzheimer disease. Data were identified from one clinical trial rated class I and three rated class II.
The researchers found that single doses of aducanumab up to 30 mg/kg were safe and well tolerated based on the class I study. Evidence was provided by all three class II studies that aducanumab reduced amyloid deposition on brain positron emission tomography at one year compared with placebo. In the class II studies, efficacy data varied by dose and outcome; aducanumab either had no effect or resulted in less worsening that was of uncertain clinical significance on the mean change on the Clinical Dementia Rating Sum-of-Boxes scores. In approximately 40 percent of individuals treated with aducanumab and 10 percent receiving placebo, adverse amyloid-related imaging abnormalities occurred.
“Until new research is available, this focused understanding of the current data is key to helping doctors, patients, and their families discuss and make decisions on whether to pursue treatment with aducanumab,” Day said in a statement.
Several authors disclosed financial ties to the pharmaceutical and health care industries.
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