Anavex Life Sciences Corp (AVXL)

[Doc328]

Is it possible the 27-28 could be predicted to decline as early AD patients? Maybe this is also part of learning about early decline with MCI types?

IMO, its very probable that their inclusion is to get two shots on goal -- one for mild Ad and one for MCI. Many studies show that the best time to make an impact is early in the disease and with PET, some MCI patients get diagnosed with AD earlier. If both groups are successful, they can include both in their final Phase 3 and if only one is successful, they can study that one in Phase 3. If none are successful, there's always A371.


MCI, when based on cognitive screens like MMSE, converts to AD at about 20% per year so many just stay at MCI x 3-5 years. Amnestic MCI (patients lost points for the short term recall and are normal elsewhere) has higher conversion to AD than non-amnestic MCI but most are still MCI at 48 weeks. Since amyloid PET and/or CSF is a criteria for entry (based on HH's AAIC talk), then all MCI patients enrolled in the P2/3 are theoretically at higher risk of progressing to AD so rate would probably be > 20%, though I doubt > 50% in 48 weeks.