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abew4me

02/16/26 1:44 PM

#658 RE: Hoskuld #657

The graph at the 21-minute mark combines four studies that totaled over 1,200 patients...so I think that is a very substantial comparison.

In regard to the MMSE Cog-11 vs. Cog-13, do you know if the FDA approved Leqembi and Kisunla using Cog-13 or Cog-11?
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Doc328

02/16/26 1:48 PM

#659 RE: Hoskuld #657

MMSE and ADAS-Cog 11 were used in the earlier AD trials. Note that the P2 had an entry criteria of MMSE 14-24 (mild and mod AD, no MCI). In this mild/mod AD population Adas Cog 11 is perfectly fine to use for this range--- it is not fine in early AD trials when 1/2 the patients are MCI

https://clinicaltrials.gov/study/NCT05686044?term=annovis&rank=5


The larger ongoing P3 (6 month/18 month) is using ADAS-Cog 13 and ADCS-iADL (similar to ADCS-ADL but just uses the instrumental or more complex ADLs vs all ADL questions) This is felt to be more sensitive to early AD (mild AD and MCI) than the ADL scale Missling chose for the 2b/3. The Annovis 6/18 trial enrolls patients who are MMSE 20-28 / CDR-G 0.5 and 1 (MCI and Mild) --- so using ADAS-Cog 13 is appropriate for this population

Look at the video minutes 9-10 at the endpoints and also
https://clinicaltrials.gov/study/NCT06709014?term=annovis&rank=3