What will the recent accelerated approval of anti-amyloid lecanemab mean for Alzheimers patients, and will it overcome stringent CMS reimbursement policies?
Aduhelm, the first new treatment for Alzheimer’s disease in nearly 20 years, may be a long-awaited milestone for AD patients and caregivers but its reception has been mixed.
Scientific evidence increasingly points to brain inflammation as a major driver of Alzheimer’s disease (AD). Researchers have discovered that amyloid, one of the hallmarks of the disease, is antimicrobial and may help the immune system fight invaders to the brain. They theorize that accumulating amyloid plaques and tau tangles in response to infection set the...
We have written previously about the need for earlier diagnosis for Alzheimer’s disease (AD) and other dementias, a capability that could both aid in the discovery and the development of new therapies, and increase the chances for better patient outcomes in slowing or preventing cognitive decline. Recently, researchers have presented data on several new non-invasive...
In early July, Biogen and Eisai announced that analysis of their 18-month Phase 2 trial of BAN2401 revealed encouraging results, showing an effect on both lowering of amyloid levels and slowing of cognitive decline in patients treated with the highest dose of the drug. This spurred some analysts to hail the news as encouraging support...
We have been thinking for some time about the importance of biomarkers in both drug discovery and clinical medicine as they relate to Alzheimer’s (and our In Vivo publication also addresses this topic in depth). At the recent American Academy of Neurology (AAN) conference, there was also widespread interest in this topic, spurred in part...
The BIO International Convention is a huge gathering each year, as around 15-18,000 representatives from across industry and around the world get together to discuss policy, partnering, and product development over the course of four days. This year’s event, to be held in Boston from June 4 – 7, should be no exception. BIO has...
Alzheimer’s disease continues to be a costly and frustrating minefield for drug developers. Most recently, Boehringer Ingelheim halted development of the phosphodiesterase type 9 (PDE9) inhibitor BI 409306 after it failed in phase 2. Merck also ended its trial of verubecestat, the company’s beta-secretase-1 (BACE1) inhibitor, in early stage Alzheimer’s disease patients for futility, a few...
Developing an Alzheimer’s disease drug has been notoriously expensive and high risk. Part of the problem has been the difficulty in identifying the right patients for clinical trials and at the right time – that is, those patients showing early signs of cognitive impairment who will progress to AD. However, new diagnostics, biomarkers, and digital...