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April 3, 2012
Bapineuzumab: An Alzheimer's Update
The bapineuzumab saga has been going on for years now. (Every Alzheimer's therapy attempt either has gone on or will go on for years; it's such a slow-moving and heterogeneous disease that the clinical trials are some of the worst in the business). The results so far have not been all that encouraging, but they haven't been discouraging enough (given the state of the field) to give up on, either. Now there's another bit of data, and it's of a piece with the rest.
This Archives of Neurology paper has some results from two small 12-month patient cohorts looking at the antibody's effect on markers for Alzheimer's in the cerebrospinal fluid (CSF). (These were patients from two larger studies who agreed to be sampled for this part). And it's. . .well, you'd hope for better. Two types of tau protein (total and phosphorylated) were monitored, and while they did show an effect compared to the beginning of the study, only the phosphorylated tau was significant versus the placebo group. And what about soluble beta-amyloid? No change at all, looking over several forms (N-terminal modified, etc.)
The paper tries (in my opinion) to put a good face on these numbers, saying that the CSF phosphorylated tau levels have correlated with brain pathology in other studies, and that the amyloid levels may well reflect other clearance pathways or binding to bapineuzumab itself, and should thus be interpreted with caution. (If there had been any trend in the numbers, though, we probably wouldn't be acting so cautiously). But as the paper says, "An important question remains whether such changes in CSF biomarkers correlate with clinical benefit". That it does, and we're going to have to wait for the phase III results in order to say anything. That has been one long-running and expensive trial, for sure, and I hope that there's something worthwhile waiting at the end of it. Alzheimer's patients (and their families) really need something to give them some hope. Maybe the ApoE4 connection will help; I understand that the Phase III trials are focusing on that. But in any case, I'm hoping for a surprise, to be honest, because my expectations aren't high.
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