In 2021, Biogen Inc.’s Aduhelm (aducanumab) became the first amyloid-targeting therapy to win U.S. FDA approval in Alzheimer’s disease. After decades and dozens of failed phase III trials, the drug was granted accelerated approval in June 2021. In January 2022, however, the U.S. Center for Medicare & Medicaid Services said it would only cover use of Alzheimer’s MAbs targeting amyloid in NIH trials or trials it approved, thus appearing to call into question the rigor of FDA-approved trials.
2021 was the year Aduhelm (aducanumab, Biogen Inc.) was approved as the first amyloid-β-busting drug for Alzheimer’s disease. And in 2022, there was as much need for an effective AD drug as ever. Aduhelm’s commercial fate was sealed with the decision of the Center for Medicare & Medicaid Services (CMS) that the drug would only be reimbursed in clinical trials approved by the CMS or the NIH.
Shanghai Raising Pharmaceutical Co. Ltd. has synthesized prodrugs of thiamine acting as amyloid-β (Aβ) protein production inhibitors reported to be useful for the treatment of neurodegenerative diseases, preferably Alzheimer's disease (AD).
Alzheimer’s disease has a higher incidence in women. This sex difference was associated with a modification of certain proteins of the immune system. According to a recent study, the drop in estrogen with menopause increased the expression in the brain of a neurotransmitter, nitric oxide (NO), generating the S-nitrosylation of complement factor C3 (abbreviated SNO-C3), which activated the microglia.
Bryostatin-1 has failed another Alzheimer’s disease (AD) study. Synaptogenix Inc. released top-line data showing the protein kinase C activator missed the primary endpoint in the company’s phase II study in treating advanced AD.
Investigators from Cerevance Inc. have reported the discovery and preclinical characterization of a novel tandem pore domain halothane-inhibited K+ channel 1 (THIK-1) inhibitor, C-101248, being developed for the treatment of neuroinflammation in Alzheimer’s disease (AD). NETSseq and histological analysis revealed that THIK-1 expression was up-regulated in microglia from different cortical regions of AD donors compared with aged matched nondemented control brains.
Researchers have identified a link between amyloid plaques and dysfunctional neuronal conduction in animal models of Alzheimer’s disease (AD). Their study, which was published in the Dec. 1, 2022, issue of Nature, suggests new ways to think about AD, as well as badly needed potential alternatives to plaque removal to fight the disease.
Eisai Co. Ltd. and Biogen Inc. presented the full data set for the Clarity Alzheimer’s disease trial of lecanemab at the 2022 Clinical Trials on Alzheimer’s Disease, which was simultaneously published in the New England Journal of Medicine. The data supported the top-line results released in September 2022.
At the recent Clinic Trials on Alzheimer’s Disease (CTAD) conference in San Francisco, Regenlife SAS presented the design for its Light4life study examining the therapeutic efficacy of the RGn600 device. This trial on more than 100 subjects will evaluate the cognitive impacts of new photobiomodulation technology.
The age-old separation of dentistry from medicine is deeply embedded in education and professional practice. Given the great advances in both disciplines in recent decades, there is a reasonable argument to be made for maintaining the divide.