KOL Highlights

• Crenezumab data was negative in a Phase II study in mild to moderate AD. The signal in not pre-specified isn’t convincing. These data likely will have ethical implications for the asymptomatic, genetic AD predisposition study in the Columbian trial. (Genentech/Roche)
• Solanezumab EXPEDITION 3 study is iffy, but KOL believes Eli Lilly is learning from trials and is in it for the long haul (LLY) with a BACE inhibitor and earlier stage compounds in its pipeline.
• TOMMORROW is enrolling faster than expected, and the trial will likely include more sophisticated pharmacogenetic analysis in addition to the prespecified stratification algorithm. (Takeda)
• KOL expects results from BACE inhibitors to be the most capable of proving or disproving the amyloid hypothesis (MRK) and thinks the rationale behind combining a BACE inhibitor and an amyloid beta antibody is sound. (NVS)
• More data is necessary to determine efficacy of pimavanserin in Alzheimer’s disease psychosis. (ACAD)
• Data from sub 40-mg citalopram showed efficacy in AD agitation. (ACT)
• More work on blood-based assays to decrease the barrier to entry trials (puncture discomfort) is necessary.