Marisa Wexler, MS, senior science writer —

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…

The National Institute on Aging (NIA) has awarded a five-year grant worth up to $5 million to support a clinical trial that will test AAV2-BDNF, an investigational gene therapy, in people with Alzheimer’s disease or mild cognitive impairment, which often precedes dementia. The therapy aims to deliver the gene BDNF to…

For the first time in almost 18 years, the U.S. Food and Drug Administration (FDA) has approved a new treatment — Aduhelm, also known as aducanumab — for Alzheimer’s disease, and a first targeted treatment for patients. With this approval, Aduhelm becomes the first disease-modifying therapy for Alzheimer’s, and…