Alzheimer's Endpoint ADAS-Cog Likely Here To Stay Despite Clinical Failures
Executive Summary
Gold standard outcome for Alzheimer's trials may have its difficulties, especially with rater error, but experts say there's no proven alternative to ADAS-cog.
You may also be interested in...
FDA Should Let Alzheimer’s Trials Rely On Single Endpoint, Group Says
Informally, FDA appears open to trials that use cognition as the only primary endpoint rather than insisting that products also show benefit on the functional side.
Looser Efficacy Standards Could Waste Taxpayer Dollars On Useless Drugs, NEJM Says
Editorial cites Lilly's failed Alzheimer's candidate solanezumab to argue that looser efficacy standards could result in Medicare paying for ineffective drugs, but it's unlikely that a Scott Gottlieb-led FDA would have approved the drug.
NIH Funding Boost Underscores Tensions Between Trump, Congress
Onmibus funding bill would increase NIH funding by $2 billion, including $120 million increase for Precision Medicine Initiative; antibiotic resistance and Alzheimer's research also slated for increase.