Alzheimer's Endpoint ADAS-Cog Likely Here To Stay Despite Clinical Failures
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.
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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.
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.
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.