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Friday, September 02, 2022 9:37:46 PM
See the paper at the link below regarding the 52 week and 148 week results for the Blarcamesine Phase 2a trial for treating mild to moderate Alzheimer's disease.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7167374/
Supplementary Figure 4: Exceptional therapeutic response
Longitudinal change in MMSE and ADCS-ADL over 148 weeks of combined studies of two patients (a and b) having SIGMAR1 gene wild type, mean high concentration levels of ANAVEX2-73 in plasma in Part B and baseline MMSE ≥20. All n=6 subjects, including patients a and b, with these response characteristics are shown in Figure 3.
An additional ten patients had “unexpected positive benefit” described by their investigator in the CRF data e.g. improved mood, increase attention, improved sleep. Eight of these patients recorded a high ANAVEX2-73 plasma concentration (≥4.0ng/ml) in Part B.
We can see that the participants that responded best GROUP1 had the following characteristics:
Baseline MMSE score of greater than or equal to 20
Sigmar1 wild type
High mean (arithmetic average) concentration of Anavex 2-73 taken orally
APOE3 and/or APOE2 alleles
Now we know that the Phase 2b/3 trial was for the treatment of participants with early stage Alzheimer's disease with the following characteristics:
Baseline MMSE score of greater or equal to 20
On average 1/3 of the 509 subjects were taking the high dose of Blarcamesine which is intended to achieve a concentration of Anavex 2-73 of greater than 4 ng/ml
What does this tell us regarding the probability of success of this trial?
Good luck and GOD bless,
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