Replies to post #466340 on Anavex Life Sciences Corp (AVXL)

[Hosai]

For what it's worth I put the FDA guidance into Google gemini and also wrote what stage would 0.5 and 1 scores be for CRD global and it said this -

Based on the FDA guidance you provided, here's the likely stage of a trial participant:

0.5 Baseline CDR-Global Score: This score suggests a participant is likely in Stage 2 of early AD.

Here's why:

The CDR-Global score of 0.5 falls within the range typically associated with Stage 2 (subtle cognitive deficits without functional impairment).
Stage 2 patients may have difficulty showing a clinically meaningful benefit on cognition in short trials due to the subtlety of the deficits.
The guidance mentions that for Stage 2, FDA might consider strong justifications for a persuasive effect on cognition measured by sensitive tests, but ideally with supporting evidence on pathophysiological changes.

[Doc328]

yes. Functional limitations are absent or very mild in MCI (Stage 3) but expected mild AD (stage 4). That's why there is an ADCS-ADL-MCI version to better query subtle functional impairments for activities of daily living. That scale was used in the lecanemab study (which was 80% MCI/20% mild compared to Anavex 60/40).