Marisa Wexler, MS, senior science writer —

The U.S. Food and Drug Administration (FDA) has put a clinical hold Denali Therapeutics’ application to begin clinical testing of DNL919, an immune-modulating medication that the company is developing to treat Alzheimer’s disease. The FDA will issue an official clinical hold letter to Denali in the next month…

A new proposal in the U.S. that Medicare cover the cost of Aduhelm (aducanumab) only for people enrolled in qualifying clinical trials has been met with outrage from the Alzheimer’s Association and decried by Biogen, which developed the treatment alongside Eisai. Issued by the U.S. Centers…

Alzheimer’s News Today brought you coverage of the latest scientific advances, developments in treatment, and clinical trials related to Alzheimer’s disease throughout 2021. We look forward to continuing to report important news for the Alzheimer’s community this year. Here are the top 10 most-read Alzheimer’s stories of 2021. No.

The Committee for Medicinal Products for Human Use, or CHMP, is recommending that Aduhelm (aducanumab) should not be approved to treat the early stages of Alzheimer’s disease. The CHMP, which is part of the European Medicines Agency (EMA), voted against recommending Aduhelm last month, and now has…

A European Medicines Agency (EMA) committee has voted against approving Biogen’s Aduhelm (aducanumab) as a treatment for Alzheimer’s disease. The EMA’s Committee for Medicinal Products for Human Use, known as CHMP, is expected to issue a formal ruling based on this so-called negative trend vote after its meeting in…

A biological framework called the “microcompetition model” may explain why people infected with herpes simplex 1 (HSV1) are at increased risk of developing Alzheimer’s disease. “These dynamics explain the observed connection reported in many studies between the virus and Alzheimer’s disease, and provide a framework for further investigations,” researchers…

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…