This comment is also interesting-
In this paper on the aducanumab Phase 1b study in prodromal and mild AD patients, the data on plaque removal are quite encouraging. As pointed out on AlzForum, the initial positive cognitive data need to be confirmed in the ongoing Phase 3 studies, and I agree with Lon Schneider’s comments on potential biases linked to the staggered design of the study.
- Bruno Pietro Imbimbo
Chiesi Farmaceutici S.p.A.- Posted: 06 Sep 2016
In my opinion, there is another source of potential bias in interpreting the cognitive results of the study; it refers to the clinical stage of dropouts. The clinical characteristics of the dropouts are not much detailed in the article, but from Table 1 and Extended Data Figure 2, it seems that 10 of 12 dropouts in the 10 mg/kg group were patients with mild AD at baseline, whereas there were only one or two dropouts among prodromal AD patients in the 10 mg/kg group (see table below). Conversely, in the placebo group the discontinuation rate was similar between prodromal and mild AD patients (21.1 percent versus 28.6 percent). The criteria for definition of prodromal AD were an MMSE of 24-30 (inclusive) and a CDR of 0.5, while for mild AD they were an MMSE of 20-26 and CDR of 0.5-1. Thus, the imbalance in the proportion of prodromal AD and mild AD dropouts in the 10 mg/kg may have contributed to the apparent slow decline observed in this treatment group.
Why there was a much higher dropout rate in mild compared to prodromal AD patients in the 10 mg/kg group? One possible explanation could be a higher incidence of ARIA-E abnormalities in the mild AD group. Compared to prodromal AD, mild AD patients may have a higher Aβ burden in brain vessels and consequently a greater risk of edema or bleeding due to Aβ removal by aducanumab. Interestingly, in the ongoing ENGAGE and EMERGE Phase 3 studies, only patients with MMSE 24-30 and CDR=0.5 at baseline were included.
I hope this may be useful in interpreting the cognitive results of the study.
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