Author Archives: Marisa Wexler MS

After reviewing interim trial data, an independent safety board has recommended that Anavex Life Sciences continues a trial, without modification, of its oral therapy Anavex 2-73 (blarcamesine) in people with early Alzheimer’s disease. The board made a similar recommendation after an interim analysis earlier this year. Such a…

Treatment with the investigational anti-tau monoclonal antibody semorinemab significantly slowed decline in a measure of cognition among people with mild-to-moderate Alzheimer’s disease in the Phase 2 LAURIET clinical trial, top-line results show. “The top line results of the Lauriet Phase 2 clinical trial of semorinemab are remarkable in that…

Federal lawmakers are asking the U.S. Food and Drug Administration (FDA) to provide additional data and documents related to the agency’s controversial decision to grant accelerated approval to Biogen‘s Aduhelm (aducanumab) as a treatment for Alzheimer’s disease. U.S. Rep. Frank Pallone, Jr., chair of the House Committee on…

Every participant in the Phase 2/3 GAIN clinical trial, which is testing Cortexyme’s experimental medication COR388 (atuzaginstat) in people with Alzheimer’s disease, showed evidence of infection by Porphyromonas gingivalis (P. gingivalis), according to a new analysis. In particular, all patients analyzed at the beginning of the study who had…

Treatment with Aduhelm (aducanumab) slows the clinical decline observed in in Alzheimer’s across a range of cognitive and functional measurements, according to a new analysis of data from a Phase 3 clinical trial. The results were presented at the Alzheimer’s Association International Conference (AAIC) 2021, held July 26–30 both…

In clinical trials of the Alzheimer’s treatment Aduhelm (aducanumab), participants who experienced a greater reduction in brain levels of amyloid plaques — the abnormal protein clumps targeted by the treatment — tended to also experience a greater treatment benefit, in terms of cognition and functional ability, according to new…

A panel of experts has crafted guidance for clinical use of Aduhelm (aducanumab), the first targeted treatment for Alzheimer’s disease recently granted accelerated approval by the U.S. Food and Drug Administration (FDA). The recommendations include criteria for determining those patients most appropriate for this once-monthly infusion treatment, and for…

On June 7, Aduhelm (aducanumab) became the first new treatment for Alzheimer’s disease to be approved by the U.S. Food and Drug Administration (FDA) in nearly two decades, and this disorder’s first targeted therapy. Scarcely a month later, the agency took the unusual step of updating…

The U.S. Food and Drug Administration (FDA) has pulled back the controversial and sweeping approval recently given to Aduhelm (aducanumab), updating the treatment’s label at its manufacturer’s request so that it is prescribed to early-stage Alzheimer’s patients only rather than all with this disease.

Aduhelm (aducanumab), approved for Alzheimer’s disease in the U.S., is most appropriate for people with mild cognitive impairment (MCI) due to the disease or early Alzheimer’s dementia, the disorders for which it was tested in clinical trials and subsequently approved, according to experts from the scientific community. The experts…