Re: So many questions...
in response to
by
posted on
Dec 06, 2019 11:57PM
"Some potentially noteworthy differences in baseline race/ethnic group, region, body weight, hsCRP and eGFR."
Slide 17: Compared to the subgroups with baseline MoCA >22, the subgroup of 97 patients with baseline MoCA <22 were less likely to be white, European, or male. They also were more likely to be Latin American and have a lower body weight.
Slide 18: When the demographics of the baseline MoCA <22 subgroup are broken down by apabetalone vs. placebo, there is no difference in % males and minimal difference in body weight. However, the apabetalone group is significantly less white (~20%) than placebo, and also the apabetalone group is less European and more Latin American than the placebo group.
Slide 19: Compared to the subgroups with baseline MoCA >22, the subgroup of 97 patients with baseline MoCA <22 had a lower eGFR and a higher percentage of patients with baseline eGFR <60. The hsCRP level in this MoCA <22 subgroup is double that of the other subgroups with MoCA >22. Alkaline phosphatase in this MoCA <22 subgroup was modestly (80 vs. 76) elevated compared to the MoCA >22 subgroups.
Slide 20: When the baseline values of the MoCA <22 subgroup are broken down by apabetalone vs. placebo, one can see that the eGFR kidney function of the placebo group is modestly lower than that of the apabetalone group. The median hsCRP is the placebo group is over double that of the apabetalone group. Median alkaline phosphatase is higher (81 vs. 77) in the apabetalone vs. placebo group.
Also, in Slide 3 Executive Summary, it states "Significant and trending changes across treatment duration in ALP and HDL (biomarkers associated with cognitive risk) were observed in patients with a baseline MoCA<22." I wonder how much these alkaline phosphatase (ALP) and HDL values changed compared to the total BETonMACE population, and whether there was any greater effect of apabetalone on ALP and HDL in the MoCA <22 compared to the MoCA >22 subgroups?
I was able to see the CTAD slides thanks to an anonymous source. Nothing really different than what was in the slides today. The ALP and HDL changes for the MoCA <22 group were in line with what was reported for the total population. The only statement that caught my eye was: "Further exploratory analysis of archived plasma samples planned for additional cognitive dysfunction markers: Plasma AB42/40 ratio, P-Tau 181, ApoE4 ratio, YKL40, Neurofilament light, etc."
BDAZ